U.S. patent application number 12/610160 was filed with the patent office on 2010-05-06 for therapy system including cardiac rhythm therapy and neurostimulation capabilities.
This patent application is currently assigned to Medtronic, Inc.. Invention is credited to Paul G. Krause, Avram Scheiner.
Application Number | 20100114217 12/610160 |
Document ID | / |
Family ID | 41463038 |
Filed Date | 2010-05-06 |
United States Patent
Application |
20100114217 |
Kind Code |
A1 |
Krause; Paul G. ; et
al. |
May 6, 2010 |
THERAPY SYSTEM INCLUDING CARDIAC RHYTHM THERAPY AND
NEUROSTIMULATION CAPABILITIES
Abstract
An implantable medical system that includes a cardiac therapy
module and a neurostimulation therapy module may identify when
neurostimulation electrodes have migrated toward a patient's heart.
In some examples, the system may determine whether the
neurostimulation electrodes have migrated toward the patient's
heart based on a physiological response to an electrical signal
delivered to the patient via the neurostimulation electrodes. In
addition, in some examples, the system may determine whether the
neurostimulation electrodes have migrated toward the patient's
heart based on an electrical cardiac signal sensed via the
neurostimulation electrodes.
Inventors: |
Krause; Paul G.; (Shoreview,
MN) ; Scheiner; Avram; (Vadnais Heights, MN) |
Correspondence
Address: |
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis
MN
55432
US
|
Assignee: |
Medtronic, Inc.
|
Family ID: |
41463038 |
Appl. No.: |
12/610160 |
Filed: |
October 30, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61110046 |
Oct 31, 2008 |
|
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|
Current U.S.
Class: |
607/5 ; 607/62;
607/9 |
Current CPC
Class: |
A61N 1/36114 20130101;
A61N 1/36514 20130101; A61N 1/36521 20130101 |
Class at
Publication: |
607/5 ; 607/62;
607/9 |
International
Class: |
A61N 1/08 20060101
A61N001/08; A61N 1/39 20060101 A61N001/39; A61N 1/362 20060101
A61N001/362 |
Claims
1. A method comprising: delivering cardiac rhythm therapy to a
patient via a first set of electrodes of a first lead electrically
connected to a cardiac therapy module; delivering an electrical
signal to a tissue site within a patient via a second set of
electrodes of a second lead electrically connected to a
neurostimulation therapy module; sensing a physiological signal;
detecting a physiological response of the patient to the electrical
signal based on the physiological signal; and controlling the
neurostimulation therapy module to selectively deliver
neurostimulation to the patient based on the detected physiological
response.
2. The method of claim 1, wherein controlling the neurostimulation
therapy module to selectively deliver neurostimulation to the
patient based on the detected physiological response comprises
controlling the neurostimulation therapy module to deliver
neurostimulation to the patient via the second set of electrodes of
the second lead if the physiological response is detected and
controlling the neurostimulation therapy module to withhold the
delivery neurostimulation to the patient via the second set of
electrodes of the second lead if the physiological response is not
detected.
3. The method of claim 2, wherein sensing the physiological signal
comprises sensing an electrical nerve signal generated by a nerve
of the patient and the physiological response comprises a response
of the nerve to the electrical signal.
4. The method of claim 2, wherein sensing the physiological signal
comprises sensing the physiological signal indicative of muscle
activity of the patient and the physiological response comprises a
response of the muscle to the electrical signal.
5. The method of claim 4, wherein the physiological signal
indicates activity of a laryngeal muscle.
6. The method of claim 2, wherein detecting the physiological
response comprises comparing an amplitude of the physiological
signal to a threshold value, and detecting the response when the
amplitude is greater than or equal to the threshold value.
7. The method of claim 2, wherein delivering the electrical signal
to the tissue site comprises delivering the electrical signal
having a first frequency, and wherein detecting the physiological
response comprises comparing a second frequency of the
physiological signal to the first frequency, and detecting the
response when the second frequency of the physiological signal is
greater or equal to the first frequency.
8. The method of claim 1, wherein controlling the neurostimulation
therapy module to selectively deliver neurostimulation to the
patient based on the detected physiological response comprises
controlling the neurostimulation therapy module to deliver
neurostimulation to the patient via the second set of electrodes of
the second lead if the physiological response is not detected and
controlling the neurostimulation therapy module to withhold the
delivery neurostimulation to the patient via the second set of
electrodes of the second lead if the physiological response is
detected.
9. The method of claim 8, wherein sensing the physiological signal
comprises sensing at least one of an electrical cardiac signal, an
acoustic signal or a pressure signal, and the physiological
response indicates cardiac capture.
10. The method of claim 9, wherein the physiological response
indicates a depolarization of a heart of the patient caused by the
electrical signal.
11. The method of claim 9, wherein the physiological signal
comprises at least one of an electrocardiogram or an electrogram,
and the physiological response comprises at least one of an R-wave
or a P-wave.
12. The method of claim 1, wherein the second lead is implanted
proximate to nonmyocardial tissue or nonvascular cardiac tissue of
the patient.
13. The method of claim 1, wherein the second lead is implanted
within vasculature of the patient.
14. The method of claim 1, wherein the cardiac rhythm therapy
comprises at least one of pacing, cardioversion or defibrillation
therapy.
15. The method of claim 1, wherein the cardiac therapy module and
neurostimulation therapy module are enclosed in separate outer
housings that are separately implantable within the patient.
16. The method of claim 1, wherein the cardiac therapy module and
neurostimulation therapy module are enclosed in a common outer
housing of an implantable medical device.
17. A system comprising: a first lead comprising a first set of
electrodes; a second lead comprising a second set of electrodes; a
cardiac therapy module electrically connected to the first set of
electrodes of the first lead, wherein the cardiac therapy module
generates and delivers cardiac rhythm therapy to a heart of the
patient via the first set of electrodes; a neurostimulation therapy
module electrically connected to the second set of electrodes of
the second lead, wherein neurostimulation therapy module generates
and delivers an electrical signal to a tissue site within the
patient via the second set of electrodes; a sensing module that
senses a physiological signal of the patient; a processor that
detects a physiological response of the patient to the electrical
signal based on the physiological signal and controls the
neurostimulation therapy module to selectively deliver
neurostimulation to the patient based on the detected physiological
response.
18. The system of claim 17, wherein the sensing module senses the
physiological signal of the patient via the first set of
electrodes.
19. The system of claim 17, wherein the sensing module senses the
physiological signal of the patient via the second set of
electrodes.
20. The system of claim 17, wherein the cardiac therapy module and
the neurostimulation therapy module are enclosed within a common
outer housing of an implantable medical device.
21. The system of claim 17, further comprising a first implantable
medical device (IMD) comprising a first outer housing enclosing the
cardiac therapy module and a second IMD comprising a second outer
housing enclosing the neurostimulation therapy module, wherein the
first and second outer housings are physically separate from each
other and separately implantable within the patient.
22. The system of claim 17, wherein the processor controls the
neurostimulation therapy module to selectively deliver
neurostimulation to the patient based on the detected physiological
response by at least controlling the neurostimulation therapy
module to deliver neurostimulation to the patient via the second
set of electrodes of the second lead if the physiological response
is detected and controlling the neurostimulation therapy module to
withhold the delivery neurostimulation to the patient via the
second set of electrodes of the second lead if the physiological
response is not detected.
23. The system of claim 22, wherein the physiological signal
comprises an electrical nerve signal generated by a nerve of the
patient, and the physiological response comprises a response of the
nerve to the electrical signal.
24. The system of claim 22, wherein the physiological signal
indicates muscle activity of the patient and the physiological
response comprises a response of the muscle to the electrical
signal.
25. The system of claim 22, wherein the processor detects the
physiological response by at least comparing an amplitude of the
physiological signal to a threshold value, and detecting the
physiological response when the amplitude is greater than or equal
to the threshold value.
26. The system of claim 22, wherein the processor detects the
physiological response by at least comparing a frequency of the
physiological signal to a threshold value, and detecting the
physiological response when the frequency is greater or equal to
the threshold value.
27. The system of claim 17, wherein the processor controls the
neurostimulation therapy module to selectively deliver
neurostimulation to the patient based on the detected physiological
response by at least controlling the neurostimulation therapy
module to deliver neurostimulation to the patient via the second
set of electrodes of the second lead if the physiological response
is not detected and controlling the neurostimulation therapy module
to withhold the delivery neurostimulation to the patient via the
second set of electrodes of the second lead if the physiological
response is detected.
28. The system of claim 27, wherein the physiological signal
comprises at least one of an electrical cardiac signal, an acoustic
signal or a pressure signal, and the physiological response
indicates cardiac capture.
29. The system of claim 28, wherein the physiological signal
comprises at least one of an electrocardiogram or an electrogram,
and the physiological response comprises at least one of an R-wave
or a P-wave.
30. The system of claim 17, wherein the second set of electrodes of
the second lead are implanted proximate to a vagus nerve of the
patient.
31. A system comprising: means for delivering cardiac rhythm
therapy to a patient via a first set of electrodes of a first lead;
means for delivering an electrical signal to a tissue site within a
patient via a second set of electrodes of a second lead; means for
sensing a physiological signal; means for detecting a physiological
response of the patient to the electrical signal based on the
physiological signal; and means for controlling the means for
delivering the electrical signal to deliver neurostimulation
therapy to the patient based on the detected physiological
response.
32. The system of claim 31, wherein the means for controlling the
means for delivering the electrical signal comprises means for
controlling the means for delivering the electrical signal to
deliver neurostimulation therapy to the patient via the second set
of electrodes of the second lead if the physiological response is
detected and means for controlling the means for delivering the
electrical signal to withhold the delivery neurostimulation therapy
to the patient via the second set of electrodes of the second lead
if the physiological response is not detected.
33. The system of claim 32, wherein the means for sensing the
physiological signal comprises means for sensing an electrical
nerve signal indicative of activity of a nerve of the patient or an
electrical muscle signal indicative of muscle activity of the
patient.
34. The system of claim 31, wherein the means for controlling the
means for delivering the electrical signal comprises means for
controlling the means for delivering the electrical signal to
deliver neurostimulation therapy to the patient via the second set
of electrodes of the second lead if the physiological response is
not detected and means for controlling the means for delivering the
electrical signal to withhold the delivery neurostimulation therapy
to the patient via the second set of electrodes of the second lead
if the physiological response is detected.
35. The system of claim 34, wherein the means for sensing the
physiological signal comprises means for sensing an electrical
cardiac signal, and the physiological response is indicative of
cardiac capture.
36. A computer-readable medium comprising instructions that cause a
programmable processor to: control a cardiac therapy module to
deliver cardiac rhythm therapy to a patient via a first set of
electrodes of a first lead electrically connected to the cardiac
therapy module; control a neurostimulation therapy module to
deliver an electrical signal to a tissue site within a patient via
a second set of electrodes of a second lead electrically connected
to the neurostimulation therapy module; control a sensing module to
sense a physiological signal; detect a physiological response of
the patient to the electrical signal based on the physiological
signal; and control the neurostimulation therapy module to
selectively deliver neurostimulation to the patient based on the
detected physiological response.
Description
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/110,046, entitled, "THERAPY SYSTEM INCLUDING
CARDIAC RHYTHM THERAPY AND NEUROSTIMULATION CAPABILITIES," and
filed on Oct. 31, 2008, the entire content of which is incorporated
herein by reference.
TECHNICAL FIELD
[0002] The disclosure relates to medical devices and, more
particularly, medical devices that deliver electrical stimulation
therapy.
BACKGROUND
[0003] A wide variety of implantable medical devices that deliver a
therapy or monitor a physiologic condition of a patient have been
clinically implanted or proposed for clinical implantation in
patients. Some implantable medical devices may employ one or more
elongated electrical leads and/or sensors. Such implantable medical
devices may deliver therapy or monitor the heart, muscle, nerve,
brain, stomach or other organs. In some cases, implantable medical
devices deliver electrical stimulation therapy and/or monitor
physiological signals via one or more electrodes or sensor
elements, at least some of which may be included as part of one or
more elongated implantable medical leads. Implantable medical leads
may be configured to allow electrodes or sensors to be positioned
at desired locations for delivery of stimulation or sensing
electrical depolarizations. For example, electrodes or sensors may
be located at a distal portion of the lead. A proximal portion of
the lead may be coupled to an implantable medical device housing,
which may contain electronic circuitry such as stimulation
generation and/or sensing circuitry. In some cases, electrodes or
sensors may be positioned on an IMD housing as an alternative or in
addition to electrodes or sensors deployed on one or more
leads.
[0004] For example, implantable cardiac devices, such as cardiac
pacemakers or implantable cardioverter defibrillators, provide
therapeutic electrical stimulation to the heart by delivering
electrical therapy signals such as pulses or shocks for pacing,
cardioversion or defibrillation pulses via electrodes of one or
more implantable leads. In some cases, an implantable cardiac
device may sense intrinsic depolarizations of the heart, and
control the delivery of therapeutic stimulation to the heart based
on the sensing. When an abnormal rhythm of the heart is detected,
such as bradycardia, tachycardia or fibrillation, an appropriate
electrical therapy (e.g., in the form of pulses) may be delivered
to restore the normal rhythm. For example, in some cases, an
implantable medical device may deliver pacing, cardioversion or
defibrillation signals to the heart of the patient upon detecting
ventricular tachycardia, and deliver cardioversion or
defibrillation therapy to a patient's heart upon detecting
ventricular fibrillation. Some medical device systems that include
a neurostimulator in addition to implantable cardiac device have
also been proposed.
SUMMARY
[0005] In general, the disclosure is directed to detecting
migration of an implanted medical lead from a target tissue site
within a patient. The lead may be electrically coupled to a
neurostimulation module of an implantable medical system that also
includes a cardiac therapy module. The cardiac therapy module and
neurostimulation module may be disposed in a common outer housing
or separate outer housings. The cardiac therapy module may provide
cardiac rhythm therapy, e.g., one or more of pacing, cardioversion,
and/or defibrillation therapy, to a heart of a patient via a first
set of electrodes. The neurostimulation module may provide
electrical stimulation therapy to a nonmyocardial tissue site
(e.g., tissue proximate a nerve) or a nonvascular cardiac tissue
site via a second set of electrodes that is separate from the first
set of electrodes used to deliver the cardiac rhythm therapy.
[0006] Features of an implantable medical system described herein
may help identify when the second set of electrodes have moved
toward the patient's heart, which may be used to control the
delivery of neurostimulation by the neurostimulation therapy
module. For example, the delivery of neurostimulation may be
suspended or otherwise adjusted upon determining that the second
set of electrodes has migrated away from a target tissue site
and/or towards the heart of the patient.
[0007] In one aspect, the disclosure is directed to a method
comprising delivering cardiac rhythm therapy to a patient via a
first set of electrodes of a first lead electrically connected to a
cardiac therapy module, delivering an electrical signal to a tissue
site within a patient via a second set of electrodes of a second
lead electrically connected to a neurostimulation therapy module,
sensing a physiological signal, detecting a physiological response
of the patient to the electrical signal based on the physiological
signal, and controlling the neurostimulation therapy module to
selectively deliver neurostimulation to the patient based on the
detected physiological response.
[0008] In another aspect, the disclosure is directed to a system
comprising a first lead comprising a first set of electrodes, a
second lead comprising a second set of electrodes, a cardiac
therapy module electrically connected to the first set of
electrodes of the first lead, wherein the cardiac therapy module
generates and delivers cardiac rhythm therapy to a heart of the
patient via the first set of electrodes, a neurostimulation therapy
module electrically connected to the second set of electrodes of
the second lead, wherein neurostimulation therapy module generates
and delivers an electrical signal to a tissue site within the
patient via the second set of electrodes, a sensing module that
senses a physiological signal of the patient, and a processor. The
processor detects a physiological response of the patient to the
electrical signal based on the physiological signal and controls
the neurostimulation therapy module to selectively deliver
neurostimulation to the patient based on the detected physiological
response.
[0009] In another aspect, the disclosure is directed to a system
comprising means for delivering cardiac rhythm therapy to a patient
via a first set of electrodes of a first lead, means for delivering
an electrical signal to a tissue site within a patient via a second
set of electrodes of a second lead, means for sensing a
physiological signal, means for detecting a physiological response
of the patient to the electrical signal based on the physiological
signal, and means for controlling the means for delivering the
electrical signal to deliver neurostimulation therapy to the
patient based on the detected physiological response.
[0010] In another aspect, the disclosure is directed to a
computer-readable medium comprising instructions that cause a
programmable processor to control a cardiac therapy module to
deliver cardiac rhythm therapy to a patient via a first set of
electrodes of a first lead electrically connected to the cardiac
therapy module, control a neurostimulation therapy module to
deliver an electrical signal to a tissue site within a patient via
a second set of electrodes of a second lead electrically connected
to the neurostimulation therapy module, control a sensing module to
sense a physiological signal, detect a physiological response of
the patient to the electrical signal based on the physiological
signal, and control the neurostimulation therapy module to
selectively deliver neurostimulation to the patient based on the
detected physiological response.
[0011] In another aspect, the disclosure is directed to a method
comprising delivering cardiac rhythm therapy to a heart of a
patient via a first set of electrodes of a first lead electrically
connected to a cardiac therapy module, delivering an electrical
stimulation signal to a tissue site within a patient via a second
set of electrodes of a second lead electrically connected to a
neurostimulation therapy module, sensing an electrical cardiac
signal with second set of electrodes of the second lead,
determining whether the second set of electrodes of the second lead
is at least a predetermined distance away from the heart of the
patient based on the electrical cardiac signal, and controlling the
neurostimulation therapy module to deliver neurostimulation therapy
to the patient if the second set of electrodes of the second lead
is the at least the predetermined distance away from the heart.
[0012] In another aspect, the disclosure is directed to a system
comprising a first lead comprising a first set of electrodes, a
second lead comprising a second set of electrodes, a cardiac
therapy module electrically connected to the first set of
electrodes of the first lead, wherein the cardiac therapy module
generates and delivers cardiac rhythm therapy to a heart of the
patient via the first set of electrodes, a neurostimulation therapy
module electrically connected to the second set of electrodes of
the second lead, wherein neurostimulation therapy module generates
and delivers an electrical stimulation signal to a tissue site
within the patient via the second set of electrodes, a sensing
module that senses an electrical cardiac signal of the patient, and
a processor. The processor determines whether the second set of
electrodes of the second lead is at least a predetermined distance
away from the heart of the patient based on the electrical cardiac
signal and controls the neurostimulation therapy module to deliver
neurostimulation therapy to the patient if the second set of
electrodes of the second lead is the at least a predetermined
distance away from the heart.
[0013] In another aspect, the disclosure is directed to a system
comprising means for delivering cardiac rhythm therapy to a heart
of a patient via a first set of electrodes of a first lead, means
for delivering an electrical stimulation signal to a tissue site
within a patient via a second set of electrodes of a second lead,
means for sensing an electrical cardiac signal with the second set
of electrodes of the second lead, means for determining whether the
second set of electrodes of the second lead is at least a
predetermined distance away from the heart of the patient based on
the electrical cardiac signal, and means for controlling the means
for delivering the electrical stimulation signal to deliver
neurostimulation therapy to the patient if the second set of
electrodes of the second lead is the at least the predetermined
distance away from the heart.
[0014] In another aspect, the disclosure is directed to a
computer-readable medium comprising instructions that cause a
programmable processor to control a cardiac therapy module to
deliver cardiac rhythm therapy to a heart of a patient via a first
set of electrodes of a first lead electrically connected to the
cardiac therapy module, control a neurostimulation therapy module
to deliver an electrical stimulation signal to a tissue site within
a patient via a second set of electrodes of a second lead
electrically connected to the neurostimulation therapy module,
control a sensing module to sense an electrical cardiac signal with
the second set of electrodes of the second lead, determine whether
the electrical cardiac signal indicates the second set of
electrodes of the second lead is at least a predetermined distance
away from the heart of the patient, and control the
neurostimulation therapy module to deliver neurostimulation therapy
to the patient if the electrical cardiac signal indicates the
second set of electrodes of the second lead is the at least the
predetermined distance away from the heart.
[0015] In another aspect, the disclosure is directed to a
computer-readable medium containing instructions. The instructions
cause a programmable processor to perform any part of the
techniques described herein.
[0016] The details of one or more examples of the disclosure are
set forth in the accompanying drawings and the description below.
Other features, objects, and advantages of the disclosure will be
apparent from the description and drawings, and from the example
statements provided below.
BRIEF DESCRIPTION OF DRAWINGS
[0017] FIG. 1 is a conceptual diagram illustrating an example
therapy system including an implantable medical device (IMD) that
delivers cardiac and neurostimulation therapy to a patient.
[0018] FIG. 2 is a conceptual diagram illustrating the IMD of FIG.
1 and the respective leads in greater detail.
[0019] FIG. 3 is a conceptual diagram illustrating another example
IMD lead configuration.
[0020] FIG. 4 is a functional block diagram of the IMD of FIG. 1,
which includes a lead migration detection module.
[0021] FIG. 5 is a function block diagram of the lead migration
detection module shown in FIG. 4.
[0022] FIG. 6 is a functional block diagram of an example medical
device programmer.
[0023] FIG. 7 illustrates an example electrical nerve signal that
includes a response to a neurostimulation signal.
[0024] FIG. 8 illustrates an example electrical cardiac signal that
includes an evoked response to the delivery of a neurostimulation
signal.
[0025] FIGS. 9-12 are flow diagrams illustrating example techniques
for selectively withholding delivery of neurostimulation therapy to
a patient based on a determination that one or more
neurostimulation leads may have migrated toward the patient's
heart.
DETAILED DESCRIPTION
[0026] The disclosure is directed toward features of a therapy
system that includes a cardiac therapy module and a
neurostimulation therapy module, where the features may help detect
whether an implanted medical lead electrically coupled to the
neurostimulation module has migrated away from a target tissue site
and/or toward a heart of a patient. The cardiac therapy module and
a neurostimulation therapy module may be enclosed in separate
housings (e.g., as part of different medical devices) or in a
common medical device housing. The cardiac therapy module may
provide cardiac rhythm therapy to a heart of a patient, e.g.,
pacing, cardioversion, and/or defibrillation therapy via one or
more electrodes. The electrodes may be intravascular or
extravascular. An extravascular tissue site may be outside of the
patient's heart, and outside of arteries, veins, or other
vasculature of the patient. The neurostimulation therapy module may
deliver electrical stimulation signals to a tissue site via
electrodes electrically connected to the neurostimulation therapy
module. The neurostimulation may help modulate an autonomic nervous
system of the patient or improve vascular tone of the patient. The
electrodes electrically connected to the neurostimulation therapy
module may be intravascular or extravascular.
[0027] In some examples, the tissue site for the neurostimulation
therapy may include at least one of a nonmyocardial tissue site or
a nonvascular cardiac tissue site. A nonmyocardial tissue site may
include a tissue site that does not include cardiac muscle (e.g.,
the myocardium). For example, a nonmyocardial tissue site may be
proximate a muscle other than cardiac muscle, an organ other than
the heart, or neural tissue. A tissue site proximate a nerve may be
a neural tissue site to which delivery of electrical stimulation
may activate the nerve. In some examples, a tissue site proximate a
nerve may be in a range of about zero centimeters to about ten
centimeters from the nerve, although other distance ranges are
contemplated and may depend upon the nerve. The nonmyocardial
tissue site may include extravascular tissue sites or intravascular
tissue sites. A nonvascular cardiac tissue site may include, for
example, a cardiac fat pad.
[0028] The target neurostimulation site to which the
neurostimulation therapy module delivers electrical stimulation may
be a sufficient distance from the heart, such that the delivery of
neurostimulation therapy to the patient via neurostimulation
electrodes electrically connected to the neurostimulation module
does not capture (e.g., evoke a cardiac contraction) the heart or
otherwise affect the rhythm of the heart. The neurostimulation lead
may change position over time, e.g., migrate from the implant site.
In some cases, this may cause the neurostimulation electrodes to
migrate towards the heart of the patient. For example, the
neurostimulation lead may be implanted intravascularly, e.g.,
within the jugular vein, and proximate to a target stimulation
site, such as the vagus nerve. Over time, the neurostimulation
electrodes may migrate from the implant site, e.g., through the
jugular vein, toward the heart of the patient.
[0029] Post-implant migration of leads or patient posture changes
may alter the initial relative positioning of the neurostimulation
lead relative to the heart. The initial relative positioning of the
neurostimulation lead relative to the heart may take place when the
neurostimulation lead is implanted within the patient. It may be
undesirable for the neurostimulation therapy module to deliver the
neurostimulation therapy to the heart of the patient because the
delivery of neurostimulation to the heart may capture the heart,
which is not the intended target for the neurostimulation. It may
also be undesirable to deliver neurostimulation to the patient when
the neurostimulation lead migrates from the intended implant site
because the neurostimulation may affect the detection of cardiac
signals by the cardiac therapy module (e.g., sensing of the
neurostimulation signals by the cardiac therapy module).
[0030] In accordance with various examples of this disclosure, a
therapy system may automatically withhold neurostimulation therapy,
e.g., prevents the neurostimulation therapy module from delivering
electrical stimulation to the patient via the neurostimulation
electrodes, when the therapy system detects that the
neurostimulation lead has migrated a certain distance away from the
implant site, or otherwise changed position. Some of the features
described herein include techniques for determining whether one or
more electrodes of the the neurostimulation lead have migrated
toward the heart and withholding the delivery of neurostimulation
via the migrated lead if an undesirable amount of lead movement is
detected.
[0031] In some examples, an implantable medical device (IMD) that
includes at least one of the neurostimulation therapy module or the
cardiac therapy module may determine whether neurostimulation
electrodes of a neurostimulation lead have migrated toward the
heart by delivering an electrical stimulation signal via the
neurostimulation lead and analyzing a physiological signal to
detect the patient's physiological response to the delivered
neurostimulation signal. The physiological response may be, for
example, a response by the patient's heart or a nerve. A
characteristic of the physiological response may indicate that the
neurostimulation electrodes of a neurostimulation lead have not
migrated from the target tissue site, such that the possibility
that delivery of neurostimulation therapy to the patient via the
neurostimulation electrodes capture the patient's heart is
reduced.
[0032] In another example, the IMD may determine whether
neurostimulation electrodes of a neurostimulation lead have
migrated towards the patient's heart based on a cardiac signal,
e.g., an electrocardiogram (ECG) or electrogram (EGM) signal,
sensed by the neurostimulation electrodes. A signal parameter of
the sensed cardiac signal, such as an amplitude, a polarity, a
frequency, or morphology of the signal, may indicate whether the
neurostimulation electrodes have migrated toward the patient's
heart, and, as a result, whether the withholding or other
adjustment to the delivery of neurostimulation therapy is
desirable.
[0033] In some examples, the IMD may also compare or correlate the
cardiac signals (e.g., ECG or EGM) sensed on via the
neurostimulation electrodes, referred to as a far field cardiac
signal, to a near field cardiac signal, which includes a cardiac
signal sensed via the cardiac therapy electrodes electrically
connected to the cardiac therapy module. If a characteristic of the
near field cardiac signal is within a threshold range of a
characteristic of the far field cardiac signal, the IMD may
determine that the neurostimulation electrodes have migrated toward
the patient's heart and that the withholding of neurostimulation
therapy is desirable.
[0034] The IMD may also utilize one or more other techniques in
addition or instead of the examples features for detecting movement
of a neurostimulation lead described above. For example, the IMD
may monitor an impedance of an electrical path between the
neurostimulation electrodes and one or more of the cardiac
electrodes to detect migration of the neurostimulation lead. The
IMD may use various modalities to determine the impedance between
the neurostimulation and cardiac leads. The IMD may compare the
determined impedance value to a threshold value and selectively
withhold therapy delivery by the neurostimulation module based on
the comparison.
[0035] While techniques for minimizing the possibility that a
neurostimulation therapy module may deliver neurostimulation that
captures of a heart of a patient are described herein with respect
to an IMD that comprises a cardiac therapy module and a
neurostimulation therapy in a common outer housing, in other
examples, the techniques described herein are also applicable to a
therapy system that includes two IMDs, where a first IMD includes
the cardiac therapy module and a second IMD includes the
neurostimulation therapy module. The first and second IMDs may have
physically separate outer housings that are separately implanted
within the patient.
[0036] FIG. 1 is a conceptual diagram illustrating an example
therapy system 10 that provides cardiac rhythm management therapy
and neurostimulation therapy to patient 12. Therapy system 10
includes implantable medical device (IMD) 16, which is connected
(or "coupled") to leads 18, 20, 22, 28, and programmer 24. IMD 16
may be subcutaneously or submuscularly implanted in the body of a
patient 12 (e.g., in a chest cavity, lower back, lower abdomen, or
buttocks of patient 12).
[0037] As described in further detail with respect to FIG. 4, IMD
16 may include a cardiac therapy module (not shown in FIG. 1) and a
neurostimulation module (not shown in FIG. 1) enclosed within outer
housing 44. The cardiac therapy module may generate and deliver
cardiac rhythm management therapy to heart 14 of patient 12, and
may include, for example, an implantable pacemaker, cardioverter,
and/or defibrillator that provide therapy to heart 14 of patient 12
via electrodes coupled to one or more of leads 18, 20, and 22. In
some examples, the cardiac therapy module may deliver pacing
pulses, but not cardioversion or defibrillation pulses, while in
other examples, the cardiac therapy module may deliver
cardioversion or defibrillation pulses, but not pacing pulses. In
addition, in further examples, cardiac therapy module may deliver
pacing, cardioversion, and defibrillation pulses. IMD 16 may
deliver pacing that includes one or both of anti-tachycardia pacing
(ATP) and cardiac resynchronization therapy (CRT).
[0038] The neurostimulation module of IMD 16 may include a signal
generator that generates and delivers electrical stimulation to a
tissue site of patient 12, e.g., tissue proximate a vagus nerve, a
spinal cord, or heart 14 of patient 12. As previously indicated, in
some examples, the tissue site may include at least one of a
nonmyocardial tissue site or a nonvascular cardiac tissue site. A
nonmyocardial tissue site may include a tissue site that does not
include cardiac muscle, e.g., the myocardium. For example, a
nonmyocardial tissue site may be proximate a muscle other than
cardiac muscle, an organ other than heart 14, or neural tissue. The
nonmyocardial tissue site may include extravascular tissue sites or
intravascular tissue sites. In the example shown in FIG. 1,
electrodes of lead 28 are position to deliver electrical
stimulation to target tissue site 40 (also referred to as "target
stimulation site") proximate a vagus nerve of patient 12. The vagus
nerve is primarily referred to herein as the target nerve for
neurostimulation therapy. However, in other examples, the target
nerve may be other nerves within patient 12, such as nerves
branching from the vagus nerve, the spinal cord, and the like. A
nonvascular cardiac tissue site can include, for example, cardiac
fat pads.
[0039] In some examples, delivery of electrical stimulation to a
tissue site proximate a nerve or a nonmyocardial tissue site that
may not be proximate a nerve may help modulate an autonomic nervous
system of patient 12. In some examples, IMD 16 may deliver
electrical stimulation therapy to a nerve of patient 12 via a lead
implanted within vasculature (e.g., a blood vessel) of patient 12.
In some examples, IMD 16 may deliver electrical stimulation that is
delivered to peripheral nerves that innervate heart 14, or fat pads
on heart 14 that may contain nerve bundles. Stimulation may be
delivered to extravascular tissue sites, for example, when lead 28
is not implanted within vasculature, such as within a vein, artery
or heart 14. In other examples, stimulation may be delivered to a
nonmyocardial tissue site via electrodes of an intravascular lead
that is implanted within vasculature.
[0040] In some examples, delivery of electrical stimulation to a
nonmyocardial tissue site may provide cardiac benefits to patient
12. For example, delivery of electrical stimulation to a
nonmyocardial tissue site by IMD 16 may help treat heart failure.
In addition, in some examples, the delivery of electrical
stimulation by IMD 16 may help modulate an autonomic nervous system
of patient 12. Delivery of electrical stimulation to a nerve of
patient 12 to may help reduce or eliminate cardiovascular
conditions such as bradycardia, tachycardia, unhealthy cardiac
contractions, ischemia, inefficient heart pumping, inefficient
collateral circulation of heart 14 or cardiac muscle trauma. In
addition, delivery of electrical stimulation may complement
antitachycardia pacing or provide back-up therapy to cardiac
therapy delivered by IMD 16.
[0041] In the example shown in FIG. 1, the neurostimulation therapy
module of IMD 16 delivers electrical stimulation therapy to a nerve
of patient 12 via a lead implanted within vasculature (e.g., a
blood vessel) of patient 12. In particular, lead 28 is implanted
such that electrodes of lead 28 are positioned within jugular vein
46 and proximate the vagus nerve (not shown). In other examples,
IMD 16 may provide electrical stimulation therapy to a
parasympathetic nerve of patient 12 other than the vagus nerve.
Stimulation of a parasympathetic nerve of patient 12 may help slow
intrinsic rhythms of heart 14, which may complement
antitachyarrhythmia therapy (e.g., antitachycardia pacing,
cardioversion or defibrillation) delivered by IMD 16. In this way,
neurostimulation therapy may help control a heart rate of patient
12 or otherwise influence cardiac function.
[0042] In other examples, electrodes of lead 28 may be positioned
to deliver electrical stimulation to any other suitable nerve
(e.g., a peripheral nerve), spinal cord, organ, muscle or muscle
group in patient 12, which may be selected based on, for example, a
therapy program selected for a particular patient. In some
examples, the neurostimulation module of IMD 16 may deliver
electrical stimulation to other sympathetic or parasympathetic
nerves, baroreceptors, the carotid sinus or a cardiac branch of the
vagal trunk of patient 12 in order to facilitate the delivery of
therapy by the cardiac therapy module of IMD 16.
[0043] In FIG. 1, leads 18, 20, and 22 extend into the heart 14 of
patient 12 to sense electrical activity (electrical cardiac
signals) of heart 14 and/or deliver electrical stimulation (cardiac
therapy) to heart 14. In particular, right ventricular (RV) lead 18
extends through one or more veins (not shown), superior vena cava
(not shown), and right atrium 30, and into right ventricle 32. Left
ventricular (LV) coronary sinus lead 20 extends through one or more
veins, the vena cava, right atrium 30, and into coronary sinus 34
to a region adjacent to the free wall of left ventricle 36 of heart
14. Right atrial (RA) lead 22 extends through one or more veins and
the vena cava, and into right atrium 30 of heart 14. In other
examples, IMD 16 and, more particularly, the cardiac therapy module
of IMD 16, may deliver stimulation therapy to heart 14 by
delivering stimulation, via the cardiac therapy module, to an
extravascular tissue site in addition to or instead of delivering
stimulation via electrodes of intravascular leads 18, 20, 22. In
such examples, therapy system 10 includes one or more extravascular
leads mechanically and electrically connected to IMD 16.
[0044] The cardiac therapy module may sense electrical signals
attendant to the depolarization and repolarization of heart 14 via
electrodes (not shown in FIG. 1) coupled to at least one of the
leads 18, 20, 22. These electrical signals within heart 14 may also
be referred to as cardiac signals or electrical cardiac signals. In
some examples, the cardiac therapy module provides pacing pulses to
heart 14 based on the electrical cardiac signals sensed within
heart 14. The configurations of electrodes used by the cardiac
therapy module for sensing and pacing may be unipolar or bipolar.
The cardiac therapy module may also provide defibrillation therapy
and/or cardioversion therapy via electrodes located on at least one
of the leads 18, 20, 22 and one or more electrodes on housing 44 of
IMD 16. IMD 16 may detect arrhythmia of heart 14, such as
fibrillation of ventricles 32 and 36, and deliver defibrillation
therapy to heart 14 in the form of electrical pulses via one or
more of leads 18, 20, and 22. In some examples, the cardiac therapy
module may be programmed to deliver a progression of therapies,
e.g., pulses with increasing energy levels, until a fibrillation of
heart 14 is stopped. IMD 16 detects fibrillation employing one or
more fibrillation detection techniques known in the art.
[0045] The neurostimulation therapy module of IMD 16 may provide a
programmable stimulation signal (e.g., in the form of electrical
pulses or a continuous signal) that is delivered to target tissue
site 40 by implantable medical lead 28, and more particularly, via
one or more stimulation electrodes carried by lead 28. Proximal end
28A of lead 28 may be both electrically and mechanically coupled to
connector 42 of IMD 16 either directly or indirectly (e.g., via a
lead extension). In particular, conductors disposed in the lead
body of lead 28 may electrically connect stimulation electrodes
(and sense electrodes, if present) of lead 28 to IMD 16. In some
examples, the neurostimulation therapy module of IMD 16 may be
electrically coupled to more than one lead directly or indirectly
(e.g., via a lead extension).
[0046] In the example of FIG. 1, one or more electrodes of lead 28
are intravascularly implanted in patient 12 proximate to target
tissue stimulation site 40, i.e., proximate to a vagus nerve (not
shown). In particular, one or more neurostimulation electrodes of
lead 28 are implanted within jugular vein 46. Lead 28 may be
inserted into the jugular vein 46 using a technique similar to that
used for implanting leads 18, 20, and 22. Implanting lead 28 near
the vagus nerve of patient 12 may be useful for delivering
neurostimulation therapy to the vagus nerve without requiring lead
28 to be subcutaneously implanted in patient 12. Implantation lead
28 within jugular vein 46 may be useful for reducing trauma to
patient 12, e.g., because lead 28 is not tunneled through
subcutaneous tissue from IMD 16 to target tissue site 40.
[0047] The distal portion of lead 28 may include one or more
electrodes (not shown) for delivering neurostimulation to target
tissue site 40. Various electrode configurations of lead 28 are
described in further detail with respect to FIGS. 2 and 3. In some
examples, lead 28 may also carry sense electrodes (not shown) to
permit IMD 16 to sense electrical signals, such as electrical
cardiac signals or electrical nerve signals from the vagus nerve or
spinal cord. Like the cardiac therapy module of IMD 16, in some
examples, the neurostimulation module may deliver stimulation based
on the electrical cardiac signals, which may be sensed by leads 18,
20, and 22. In some examples, described in greater detail below,
the neurostimulation module may also deliver stimulation based on
electrical cardiac signals sensed via lead 28.
[0048] In some examples, like the cardiac therapy module, the
neurostimulation module of IMD 16 may also adjust and/or deliver
therapy in response to a sensed cardiac event, e.g., depolarization
or repolarization of heart 14, or an arrhythmia. For example, if
the neurostimulation module delivers therapy to control heart rate,
the sensed depolarization and repolarization of heart 14 may
provide feedback for therapy adjustment. As another example, the
neurostimulation module may deliver therapy to control heart rate
in response to a sensed arrhythmia, which may include abnormal
heart rhythms such as bradycardia, tachycardia or fibrillation. A
sensing module of IMD 16 may detect an arrhythmia using any
suitable technique, such as techniques that rely on detected
electrical cardiac signals generated by the depolarization and
repolarization of heart 14, heart rate, or hemodynamic parameters,
such as blood oxygen levels, blood pressure, stroke volume, and the
like.
[0049] In some cases, the delivery of neurostimulation by the
neurostimulation module of IMD 16 may help eliminate or reduce the
demands of pacing or defibrillation provided by the cardiac therapy
module. This may help conserve the energy consumed by IMD 16 to
manage the patient's cardiac condition. In other examples, the
delivery of neurostimulation by the neurostimulation module of IMD
16 may help prevent or reduce the tendency of heart 14 to beat
irregularly. Thus, in some examples, the neurostimulation module of
IMD 16 may deliver therapy when the cardiac therapy module is not
delivering therapy. This may help reduce the frequency with which
the cardiac therapy module generates and delivers therapy to
terminate an arrhythmia of heart 14.
[0050] In some examples, depending upon the target tissue site for
the neurostimulation, the delivery of electrical stimulation by the
neurostimulation module may also mitigate perceptible discomfort
generated from the delivery of pacing pulses or
cardioversion/defibrillation shocks by the cardiac therapy module.
For example, if IMD 16 also delivers electrical stimulation to a
spinal cord of patient 12, e.g., via an additional lead (not
shown), the neurostimulation may produce paresthesia, which may
help reduce the discomfort felt by patient 12 from the delivery of
stimulation by the cardiac therapy module.
[0051] In general, the cardiac and neurostimulation modules of IMD
16 may deliver therapy at substantially the same time and/or at
different times. For example, a processor within IMD 16 may control
the cardiac and neurostimulation modules to deliver therapy
substantially concurrently in response to detection of
fibrillation. Additionally or alternatively, the neurostimulation
module may provide neurostimulation prior to and/or subsequent to a
defibrillation shock delivered by the cardiac therapy module. Other
functions of therapy system 10, such as sensing electrical signals,
may be performed coincident and/or in alternation with therapy
delivery by the cardiac therapy module and/or neurostimulation
module of IMD 16.
[0052] In some examples, the neurostimulation module may deliver
neurostimulation therapy to patient 12 independently of the cardiac
rhythm therapy delivered by the cardiac therapy module of IMD 16.
For example, the neurostimulation module may be programmed to
deliver neurostimulation to patient 12 according to a schedule that
is determined independently of the actual delivery of cardiac
therapy delivered by the cardiac therapy module. The schedule may
be determined, for example, by a clinician based on a trial
stimulation period in which multiple neurostimulation therapy
schedules are tested on patient 12. The schedule may dictate when
the neurostimulation module actively delivers electrical
stimulation to patient 12 and when the neurostimulation module does
not actively deliver electrical stimulation to patient 12.
[0053] In accordance with various examples of this disclosure, IMD
16 includes features for determining whether lead 28 has migrated
from target tissue site 28 and/or towards heart 14. Although
neurostimulation lead 28 is implanted proximate to target tissue
site 40 and may include one or more fixation mechanisms that help
secure the position of lead 28 within jugular vein 46, the position
of lead 28 may change over time, e.g., migrate or drift from the
implant site. Post-implant migration of lead 28 or changes in the
posture of patient 12 may alter the position of lead 28 relative to
heart 14. It may be desirable to determine whether lead 28 has
migrated toward heart 14, e.g., determine whether the
neurostimulation electrodes of lead 28 are within an particular
distance of heart 14, because neurostimulation delivered by the
neurostimulation electrodes of lead 28 may capture heart 14, or
affect sensing of electrical cardiac signals by IMD 16. For
example, the neurostimulation therapy module of IMD 16 may generate
and deliver a relatively high frequency neurostimulation signal
(e.g., about 50 Hertz (Hz).
[0054] IMD 16 may utilize one or more techniques for determining
whether lead 28 has migrated from the implant site or otherwise
changed position relative to heart 14, the determination of which
may be used to selectively withhold or suspend delivery of
neurostimulation to patient 12 via lead 28.
[0055] In some example, IMD 16 may determine whether
neurostimulation therapy to patient 12 should be withheld by
delivering an electrical stimulation signal via one or more of the
electrodes of lead 28, and analyzing a physiological signal to
detect a response to the stimulation signal. In this way, the
physiological signal may indicate a physiological response that
indicates whether lead 28 has migrated from target tissue site 40.
The physiological response may indicate whether lead 28 has
migrated from target tissue site 40, in which case IMD 16 may
adjust the delivery of neurostimulation to patient 12 (e.g., by
suspending the delivery of neurostimulation or decreasing the
intensity of neurostimulation). In this way, IMD 16 may selectively
delivery neurostimulation therapy to patient 12 based on a sensed
physiological response to the delivery of neurostimulation
therapy.
[0056] In some examples, IMD 16 may analyze the physiological
signal by analyzing an electrical muscle or nerve signal to detect
a response to the stimulation signal. The characteristic of the
electrical muscle or nerve signal that indicates the desired
response to the delivery of the electrical stimulation signal by
the neurostimulation therapy module of IMD 16 may be, for example,
an amplitude or frequency of the electrical signal. The target
characteristic of the electrical muscle or nerve signal may be
determined by a clinician at any suitable time when lead 28 is
known to be in the desired location within patient 12, e.g.,
immediately after lead 28 is implanted within patient 12.
[0057] The electrical muscle signal may be an electrical signal
indicative of a movement of a muscle that may be activated by the
neurostimulation, e.g., because the target nerve innervates the
muscle. For example, in FIG. 1, following the delivery of a
neurostimulation signal, IMD 16 may monitor an electrical signal
indicative of the vibration of a laryngeal muscle. The movement of
the muscle may be detected via en electromyogram (EMG) sensed via
the sense electrodes of lead 28 or via an acoustic sensor, a
pressure sensor, an accelerometer, or a piezoelectric sensor. The
acoustic sensor, pressure sensor, accelerometer, or piezoelectric
sensor may be located on a distal end of lead 28, located on a
distal end of an additional lead (not shown) coupled to IMD 16, or
located within the housing of IMD 16. Alternatively, the acoustic
sensor, pressure sensor, accelerometer, or piezoelectric sensor may
be a sensor implanted within patient 12 that communicates with IMD
16 and is physically separate from lead 28 and IMD 16.
[0058] IMD 16 may sense the electrical signal indicative of muscle
movement (referred to herein as an "electrical muscle signal") to
determine whether the stimulation signal is delivered to target
tissue site 40 and a desirable distance from heart 14. A change in
the muscle movement in response to the delivery of the
neurostimulation signal may indicate that the coupling between the
electrodes of lead 28 and the nerve innervating the muscle has
changed, and, thus, lead 28 has migrated away from the target
tissue site 40. For example, in the case of vagus nerve
stimulation, a decrease in frequency of the vibration of the
laryngeal muscle in response to the delivery of the
neurostimulation signal may indicate that lead 28 has changed
position relative to target tissue site 40. IMD 16 may, for
example, compare the frequency of the sensed electrical muscle
signal to a threshold value to determine whether lead 28 has
moved.
[0059] The electrical nerve signal may be an electrical signal
generated by a nerve, such as the target nerve for the
neurostimulation therapy or a branch thereof, in response to an
electrical stimulation signal delivered by the electrodes of lead
28. The response to the electrical stimulation signal may indicate,
for example, whether the neurostimulation signal captured the
nerve, and, therefore, is within a desired distance of the nerve.
In the example shown in FIG. 1, the target nerve may be the vagus
nerve, although other types of nerves are contemplated for the
neurostimulation therapy. The electrical nerve signal may be sensed
between two or more electrodes of lead 28. IMD 16 may analyze the
electrical nerve signal for a response, for example, by measuring
an amplitude of the electrical nerve signal and comparing the
determined value to a threshold value. In this case, the electrical
nerve signal may have a baseline amplitude value and a response to
the stimulation signal may be characterized by a spike in
amplitude. The nerve response may be characterized by an amplitude
or other characteristics of a sensed electrical signal.
[0060] If IMD 16 does not detect an appropriate physiological
response to the delivery of the stimulation signal, e.g., via the
electrical muscle or nerve signal, then IMD 16 may withhold (e.g.,
suspend) the delivery of neurostimulation therapy to patient 12 or
otherwise adjust the delivery of neurostimulation therapy (e.g.,
adjust the amplitude or frequency of the neurostimulation). An
appropriate physiological response to the delivery of the
stimulation signal may be characterized by a sensed electrical
signal that has a particular signal characteristic, such as a
particular amplitude. The signal characteristic may be determined
by a clinician at any suitable time when lead 28 is known to be
located at target tissue site 40, e.g., immediately after lead 28
is implanted within patient 12. IMD 16 may withhold the delivery of
neurostimulation therapy to patient 12 because the absence of the
appropriate physiological response detected via electrical muscle
or nerve signal may indicate that the electrodes of
neurostimulation lead 28 have migrated from target tissue site 40.
That is, the sensed electrical nerve or muscle signal may indicate
that the neurostimulation signal no longer generates a desired
response at target tissue site 40. The absence of the appropriate
physiological response to the delivery of the stimulation signal
may be referred to as a loss of nerve capture. If IMD 16 detects
nerve capture, e.g., via the appropriate physiological response to
the neurostimulation signal, the IMD may continue to operate
normally.
[0061] As another example, IMD 16 may deliver an electrical
stimulation signal via one or more electrodes carried by lead 28
and analyze a sensed cardiac signal (e.g., an ECG or EGM signal) to
detect a response to the stimulation signal. The ECG or EGM signal
may be sensed via the neurostimulation electrodes electrically
connected to the neurostimulation therapy module of IMD 16 via lead
28, or by the cardiac therapy electrodes electrically connected to
the cardiac therapy module of IMD 16. In this example, IMD 16 may
withhold delivery of neurostimulation therapy if a cardiac response
to the neurostimulation therapy is detected via the sensed cardiac
signal. The response may be referred to as an evoked response,
which indicates cardiac capture. Cardiac capture may indicate that
the neurostimulation signal stimulated heart 14. If IMD 16 does not
detect cardiac capture in response to the delivery of a
neurostimulation signal, IMD 16 may continue to operate normally.
In this way, IMD 16 may selectively delivery neurostimulation
therapy to patient 12 based on a sensed cardiac signal.
[0062] In other examples, IMD 16 may selectively withhold delivery
of neurostimulation to patient 12 based on a cardiac signal, e.g.,
an ECG or EGM signal, sensed by the neurostimulation electrodes.
The amplitude of the sensed cardiac signal may indicate whether the
neurostimulation electrodes of lead 28 have migrated toward heart
14. In some examples, IMD 16 may compare an amplitude of the sensed
ECG or EGM signal to a threshold value to determine whether the
delivery of neurostimulation should be withheld. As the
neurostimulation electrodes move closer to heart 14, the amplitude
of an ECG or EGM signal sensed via the neurostimulation electrodes
of lead 28 may change, e.g., increase or decrease, because of the
proximity to heart 14. Thus, in some examples, IMD 16 may withhold
the delivery of neurostimulation via the neurostimulation
electrodes based on a comparison of the amplitude of the sensed ECG
or EGM signal to a threshold value. In other examples, a polarity,
morphology, or frequency content of an ECG or EGM signal may change
dye to movement of lead 28 because the proximity of lead 28
relative to heart 14 may change. IMD 16 may selectively withhold
delivery of neurostimulation based on the comparison of the
polarity, morphology, or frequency content to a threshold
value.
[0063] IMD 16 may also selectively withhold delivery of
neurostimulation to patient 12 based on the presence or absence of
one or both of a P-wave and an R-wave in an ECG or EGM signal
sensed by lead 28. As one example, IMD 16 may analyze the ECG or
EGM signal to determine the extent to which a P-wave or an R-wave
are present in the sensed ECG or EGM signal. In this example, IMD
16 may determine the size of each of the P-wave and the R-wave,
e.g., through integration or based on the amplitude, and compare
the determined sizes of the R-wave and P-wave to each other. For
example, IMD 16 may compare the size of the P-wave and the R-wave
to determine a value that represents the size ratio between the
R-wave and the P-wave. The size ratio between the R-wave and P-wave
of a cardiac signal sensed via the electrodes of lead 28 may
indicate whether lead 28 has migrated toward heart 14.
[0064] IMD 16 may control therapy, e.g., by selectively withhold
delivery of neurostimulation, to patient 12 based on the comparison
of the ratio value of the R-wave and P-wave sizes to a threshold
value. When lead 28 is located at target tissue site 40, e.g.,
immediately after lead 28 is implanted in patient 12, the ratio of
the P-wave to the R-wave may be determined and stored as a
threshold value. IMD 16 may then determine a range of values
centered around the determined value, and the range may be stored
as a threshold range. If lead 28 migrated into right atrium 30 of
heart 14, the ratio of the P-wave to the R-wave may be relatively
large, e.g., greater than or equal to the threshold value and/or
outside the threshold range, because the P-wave may be greater in
size than the R-wave. If, however, lead 28 migrated into right
ventricle 32, the ECG or EGM signal may include an R-wave, but not
a P-wave or a relatively small P-wave. In this case, the ratio of
the P-wave to the R-wave may be relatively small, e.g., less than
or equal to the threshold value and/or outside the threshold range.
Thus, IMD 16 may compare the determined ratio value to the range of
values and selectively withhold delivery of neurostimulation to
patient 12 based on the comparison of the ratio of the R-wave and
P-wave sizes to a threshold value or threshold range.
[0065] In other examples, IMD 16 may determine a change in an
amplitude, a polarity, a morphology, or frequency content of the
ECG or EGM signal sensed via the neurostimulation electrodes of
lead 28 over time and compare the determined value to a threshold
value. A rate of change of the amplitude, polarity, morphology, or
frequency content of the ECG or EGM signal over time may be used to
track migration of the neurostimulation lead. For example, a sudden
increase in the amplitude of the cardiac signal sensed via the
neurostimulation electrodes may indicate the neurostimulation
electrodes have migrated.
[0066] In some examples, IMD 16 may also compare or correlate the
cardiac signals (e.g., ECG or EGM) sensed on via the
neurostimulation electrodes of lead 28, referred to as a far field
cardiac signal, to a near field cardiac signal, which includes a
cardiac signal sensed via the cardiac therapy electrodes
electrically connected to the cardiac therapy module via leads 18,
20, 22. Comparing the near and far field cardiac signals may
include, for example, comparing an amplitude, a polarity,
morphology, or frequency content of the signals to each other. For
example, the relative difference in amplitudes of the near field
and far field cardiac signals may indicate whether the
neurostimulation electrodes have migrated toward heart 14, and
whether the withholding of neurostimulation therapy is desirable.
For example, if the amplitude of the near field cardiac signal is
within a threshold range of the far field cardiac signal, IMD 16
may determine that the neurostimulation electrodes have migrated
toward heart 14 and that the withholding of neurostimulation
therapy is desirable.
[0067] Instead of or in addition to the comparison of amplitudes of
the near field and far field cardiac signals, IMD 16 may correlate
a portion of the near and far field cardiac signals to determine
whether the electrodes of lead 28 have moved toward heart 14. A
relatively high correlation between the near field and far field
cardiac signals may indicate that electrodes of lead 28 may have
migrated toward heart 14, such that withholding of neurostimulation
therapy is desirable. The correlation that indicates a relatively
high correlation may be selected by a clinician.
[0068] IMD 16 may also utilize one or more other techniques in
addition or alternative to examples of features for detecting
movement of electrodes of lead 28 described above. For example, IMD
16 may monitor an impedance of an electrical path between the
neurostimulation electrodes of lead 28 and one or more of the
cardiac electrodes of leads 18, 20, 22 to detect migration of
neurostimulation lead 28. IMD 16 may use various modalities, e.g.,
a tripolar or a quadrapolar configuration, to determine the
impedance of the electrical path between the neurostimulation and
cardiac leads. IMD 16 may compare the determined impedance value to
a threshold value and selectively withhold therapy delivery by the
neurostimulation module based on the comparison.
[0069] As another example, IMD 16 may monitor a heart rate or heart
rate variability of patient 12 to detect changes in the efficacy of
neurostimulation. A decrease in the efficacy of neurostimulation
may indicate that lead 28 has migrated from target tissue site 40.
Accordingly, IMD 16 may withhold delivery of neurostimulation to
patient 12 upon detecting a decrease in efficacy of
neurostimulation.
[0070] In each of these examples, IMD 16 may transmit information
to programmer 24 indicating that lead 28 has migrated from the
implant site or otherwise changed position relative to heart 14,
and/or neurostimulation therapy has been suspended in response to
detecting the migration of lead 28. Upon receiving the information,
programmer 24 may upload the received information to a remote
server, from which a clinician may access the data (such as a
remote server of the CareLink Network available from Medtronic,
Inc. of Minneapolis, Minn.) or display an appropriate message that
alerts the user (e.g., patient 12 or a clinician). Upon receiving
the message via programmer 24, a clinician may perform imaging
procedures, such as fluoroscopy, x-ray imaging, magnetic resonance
imaging (MM), or ultrasound imaging, to determine the location of
lead 28, to determine the position of lead 28 within patient 12.
Additionally or alternatively, IMD 16 may generate an alert that
may be detected by patient 12. The alert may be an audible alert,
such as a beeping sound, or a tactile alert, such as a vibration
emitted by IMD 16 or programmer 24.
[0071] In some examples, programmer 24 may be a handheld computing
device or a computer workstation. Programmer 24 may include a user
interface that receives inputs from a user. The user interface may
include, for example, a keypad and a display, which may for
example, be a cathode ray tube (CRT) display, a liquid crystal
display (LCD) or light emitting diode (LED) display. The keypad may
take the form of an alphanumeric keypad or a reduced set of keys
associated with particular functions. Programmer 24 can
additionally or alternatively include a peripheral pointing device,
such as a mouse, via which a user may interact with the user
interface. In some examples, a display of programmer 24 may include
a touch screen display, and a user may interact with programmer 24
via the display.
[0072] A user, such as a physician, technician, or other clinician,
may interact with programmer 24 to communicate with IMD 16. For
example, the user may interact with programmer 24 to retrieve
physiological or diagnostic information from IMD 16. A user may
also interact with programmer 24 to program IMD 16, e.g., select
values for operational parameters of IMD 16.
[0073] For example, the user may use programmer 24 to retrieve
information from IMD 16 regarding the rhythm of heart 14, trends
therein over time or tachyarrhythmia episodes. As another example,
the user may use programmer 24 to retrieve information from IMD 16
regarding other sensed physiological parameters of patient 12, such
as electrical depolarization/repolarization signals from the heart
(e.g., EGM signals), intracardiac or intravascular pressure,
activity, posture, respiration or thoracic impedance.
[0074] The user may use programmer 24 to program a therapy
progression for IMD 16. As one example, programmer 24 may select
electrodes (i.e., an electrode combination) with which the cardiac
therapy module of IMD 16 may deliver defibrillation pulses, select
waveforms for the defibrillation pulse or select or configure a
fibrillation detection algorithm for IMD 16. The user may also use
programmer 24 to program aspects of other therapies provided by the
cardiac therapy module of IMD 16, such as cardioversion or pacing
therapies.
[0075] The user may also use programmer 24 to program aspects of
the neurostimulation module. The therapy parameters for the
neurostimulation module of IMD 16 may include an electrode
combination for delivering neurostimulation signals, as well as an
amplitude, which may be a current or voltage amplitude, and, if the
neurostimulation module delivers electrical pulses, a pulse width,
and a pulse rate for stimulation signals to be delivered to patient
12. The electrode combination may include a selected subset of one
or more electrodes located on implantable lead 18 coupled to IMD 16
and/or a housing of IMD 16. The electrode combination may also
refer to the polarities of the electrodes in the selected subset.
By selecting particular electrode combinations, a clinician may
target particular anatomic structures within patient 12. In
addition, by selecting values for amplitude, pulse width, and pulse
rate, the physician can attempt to generate an efficacious therapy
for patient 12 that is delivered via the selected electrode
subset.
[0076] As another example, the user may use programmer 24 to
retrieve information from IMD 16 regarding the performance or
integrity of IMD 16 or other components of the relevant therapy
system 10, such as leads 18, 20, 22, 28 or a power source of IMD
16. With the aid of programmer 24 or another computing device, a
user may select values for therapy parameters for controlling
therapy delivery by the cardiac and neurostimulation modules of IMD
16. The values for the therapy parameters may be organized into a
group of parameter values referred to as a "therapy program" or
"therapy parameter set." "Therapy program" and "therapy parameter
set" are used interchangeably herein.
[0077] Programmer 24 may communicate with IMD 16 via wireless
communication using any techniques known in the art. Examples of
communication techniques may include, for example, low frequency or
radiofrequency (RF) telemetry, but other techniques are also
contemplated. In some examples, programmer 24 may include a
programming head that may be placed proximate to the patient's body
near the IMD 16 implant site in order to improve the quality or
security of communication between IMD 16 and programmer 24.
[0078] FIG. 2 is a conceptual diagram illustrating IMD 16 and leads
18, 20, 22, and 28 of therapy system 10 in greater detail. In
general, leads 18, 20, and 22 may be electrically coupled to the
cardiac therapy module of IMD 16 and lead 28 may be electrically
coupled to the neurostimulation module of IMD 16. In some examples,
proximal ends of leads 18, 20, 22, and 28 may include electrical
contacts that electrically couple to respective electrical contacts
within connector block 42 of IMD 16. In addition, in some examples,
leads 18, 20, 22, and 28 may be mechanically coupled to connector
block 42 with the aid of set screws, connection pins or another
suitable mechanical coupling mechanism.
[0079] Each of the leads 18, 20, 22, and 28 includes an elongated
insulative lead body, which may carry a number of concentric coiled
conductors separated from one another by tubular insulative
sheaths. Other lead configurations are also contemplated, such as
configurations that do not include coiled conductors. In the
illustrated example, lead 18 includes electrodes 50, 52, and 72,
lead 20 includes electrodes 54, 56, and 74, lead 22 includes
electrodes 58, 60, and 76, and lead 28 includes electrodes 80-83.
Bipolar electrodes 50 and 52 are located proximate to a distal end
of lead 18. In addition, bipolar electrodes 54 and 56 are located
proximate to a distal end of lead 20 and bipolar electrodes 58 and
60 are located proximate to a distal end of lead 22.
[0080] Electrodes 50, 54, and 58 may take the form of ring
electrodes, and electrodes 52, 56, and 60 may take the form of
extendable helix tip electrodes mounted retractably within
insulative electrode heads 62, 64, and 66, respectively. Each of
the electrodes 50, 52, 54, 56, 58, 60, 72, 74, and 76 may be
electrically coupled to a respective one of the conductors within
the lead body of its associated lead 18, 20, 22, and thereby
coupled to respective ones of the electrical contacts on the
proximal end of leads 18, 20 and 22.
[0081] Electrodes 50, 52, 54, 56, 58, 60, 72, 74, and 76 may sense
electrical signals attendant to the depolarization and
repolarization of heart 14. The electrical signals are conducted to
IMD 16 via the respective leads 18, 20, 22. In some examples, IMD
16 also delivers pacing pulses via electrodes 50, 52, 54, 56, 58,
and 60 to cause depolarization of cardiac tissue of heart 14. In
some examples, IMD 16 includes one or more housing electrodes. In
FIG. 2, IMD 16 includes a single housing electrode 68, which may be
formed integrally with an outer surface of hermetically-sealed
housing 44 of IMD 16 or otherwise coupled to housing 44. In some
examples, housing electrode 68 is defined by an uninsulated portion
of an outward facing portion of housing 44 of IMD 16. Other
division between insulated and uninsulated portions of housing 44
may be employed to define two or more housing electrodes. In some
examples, housing electrode 68 comprises substantially all of
housing 44. Any of the electrodes 50, 52, 54, 56, 58, 60, 72, 74,
and 76 may be used for unipolar sensing or pacing in combination
with housing electrode 68. As described in further detail with
reference to FIG. 4, housing 44 of IMD 16 may enclose a signal
generator that generates cardiac pacing pulses and defibrillation
or cardioversion shocks, as well as a sensing module for monitoring
electrical cardiac signals of heart 14.
[0082] Leads 18, 20, and 22 also include elongated electrodes 72,
74, 76, respectively, which may take the form of a coil. IMD 16 may
deliver defibrillation pulses to heart 14 via any combination of
elongated electrodes 72, 74, 76, and housing electrode 68.
Electrodes 68, 72, 74, 76 may also be used to deliver cardioversion
pulses to heart 14. Electrodes 72, 74, 76 may be fabricated from
any suitable electrically conductive material, such as, but not
limited to, platinum, platinum alloy or other materials known to be
usable in implantable defibrillation electrodes.
[0083] In particular, a sensing module of IMD 16 may sense
electrical physiological signals of patient 12 via two or more of
electrodes 50, 52, 54, 56, 58, 60, 72, 74, and 76. The electrical
signals may be used by the cardiac therapy module of IMD 16 to
modulate therapy. The cardiac therapy module of IMD 16 may deliver
pacing pulses via any combination of electrodes 50, 52, 54, 56, 58,
60, 72, 74, and 76 and housing electrode 68, e.g., any unipolar or
bipolar electrode configuration, or cause depolarization of cardiac
tissue of heart 14. The cardiac therapy module of IMD 16 may
alternatively or additionally deliver defibrillation and/or
cardioversion pulses to heart 14 via electrodes 50, 52, 54, 56, 58,
60, 72, 74, and 76. Electrodes 72, 74, and 76 may be useful in
delivering high energy defibrillation pulses to heart 14.
[0084] Leads 18, 20, and 22 and lead 28 may be utilized to deliver
different therapies. For example, the cardiac module of IMD 16 may
deliver therapy directly to heart 14, e.g., pacing, cardioversion,
and/or defibrillation signals and neurostimulation module may
deliver stimulation signals to a tissue site proximate a nerve. In
some examples, neurostimulation lead 28 is implanted
intravascularly within jugular vein 46 (FIG. 1) and proximate to
the vagus nerve of patient 12. With respect to FIG. 1, lead 28 is
implanted at target tissue site 40 which is proximate to a vagus
nerve and located a sufficient distance away from heart 14 such
that neurostimulation therapy is not likely to capture heart 14. In
some examples, a clinician may implant leads 18, 20, 22, and 28 in
any order because each of the leads may be inserted into the
jugular vein 46 through the same opening.
[0085] When implanted, the neurostimulation module of IMD 16 may
deliver neurostimulation via any combination of electrodes 80, 81,
82, 83 carried by lead 28 and housing electrode 68. In general, the
neurostimulation module of IMD 16 delivers neurostimulation to the
vagus nerve (not shown) of patient 12. In some examples, the
neurostimulation module may deliver a stimulation signal between
one of electrodes 80-83 and housing electrode 68, i.e., in a
unipolar configuration. As another example, the neurostimulation
module may deliver a stimulation signal between a plurality of
electrodes 80-83, e.g., in a bipolar configuration.
[0086] In some examples, electrodes 80-83 may take the form of
ring, partial ring or segmented electrodes. Ring electrodes may be
relatively simple to program, in comparison to a complex electrode
array geometry described below, and are capable of delivering an
electrical field to any tissue adjacent to the respective
electrodes 80-83, such as tissue at target tissue site 40,
including tissue proximate to the vagus nerve and laryngeal muscle
tissue. In other examples, at least one of the electrodes 80-83 may
have a different configuration. For example at least one of
electrodes 80-83 may take the form an extendable helix tip
electrode. The helix tip electrode may be mounted retractably
within an insulative electrode heads similar to that of insulative
electrode heads 62, 64, and 66 of leads 18, 20, 22. The extendable
tip electrode may be useful for fixing lead 28 within jugular vein
46 (FIG. 1). For example, the helix may be introduced into the wall
of jugular vein 46 proximate to target tissue site 40 for the
neurostimulation therapy.
[0087] In other examples, at least one of the electrodes 80-83 may
have a complex electrode array geometry that is capable of
producing shaped electrical fields. The complex electrode array
geometry may include multiple electrodes (e.g., partial ring or
segmented electrodes) around the outer perimeter of lead 28, rather
than one ring electrode. In the example shown in FIG. 2, lead 28
includes four electrodes 80-83, but may include any suitable number
of electrodes, such as fewer than four electrodes or greater than
four electrodes (e.g., eight or sixteen electrodes). One or more of
electrodes 28 may also be used for sensing electrical activity of
patient 12, such as electrical cardiac signals, EMG signals of
tissue proximate to target tissue site 40, or electrical nerve
signals. Lead 28 may also include one or more sensors that generate
an electrical signal based on a physiological parameter, such as a
pressure sensor that converts vibrations of laryngeal muscle into
an electrical signal.
[0088] The configuration, type, and number of electrodes 80-83 and
lead 28 illustrated in FIG. 2 is merely exemplary. In other
examples, IMD 16 may be coupled to any suitable number of
neurostimulation leads with any suitable number and configuration
of electrodes for delivering neurostimulation therapy to a target
tissue site. Moreover, lead 28 may comprise a shape other than a
cylindrical shape. As an example, lead 28 may comprise a
paddle-shaped portion that carries electrodes 80-83.
[0089] In other examples of therapy systems that provide cardiac
and neurostimulation therapy to patient 12, a therapy system may
include any suitable number of leads coupled to IMD 16. For
example, other examples of therapy systems may include fewer than
or more than three transvenous leads, such as a single lead that is
coupled to the cardiac therapy module of IMD 16 and extends into
right atrium 30 or right ventricle 32, or two leads that extend
into a respective one of the right ventricle 32 and right atrium 30
(shown in FIG. 3). In other examples a suitable number of leads
coupled to a cardiac therapy module of IMD 16 may be implanted
proximate to, but outside of heart 14 (referred to as extravascular
leads). Electrodes carried by extravascular leads may comprise
subcutaneous, submuscular, epicardial, and/or intramural
electrodes.
[0090] FIG. 3 is a conceptual diagram illustrating an example
therapy system 90, which includes IMD 92 electrically connected to
two cardiac leads 18, 22, rather than three leads as shown in FIGS.
1 and 2, and neurostimulation lead 28. Leads 18, 22 are implanted
within right ventricle 32 and right atrium 30, respectively.
Therapy system 90 shown in FIG. 2 may be useful for providing
defibrillation and pacing pulses to heart 14. IMD 92 operates
similar to IMD 16 (FIGS. 1 and 2) and includes a cardiac therapy
module for delivering defibrillation and pacing pulses to heart 14
and a neurostimulation module for delivering neurostimulation at
target tissue site 40 to modulate an autonomic nervous system of
patient 12. In particular, IMD 92 may also include various features
attributed to IMD 16 herein, such as the features used to determine
whether electrodes 80-83 of leads 28 have migrated away from target
tissue site 40 (FIG. 1) and towards heart 14.
[0091] FIG. 4 is a functional block diagram of an example
configuration of IMD 16, which includes processor 100, memory 102,
cardiac therapy module 104, neurostimulation therapy module 106,
telemetry module 108, power source 110, and lead migration
detection module 120. Cardiac therapy module 104 includes signal
generator 112 and sensing module 114. Neurostimulation therapy
module 106 includes signal generator 116 and sensing module 118.
The components of IMD 16 shown in FIG. 4 may be substantially
enclosed within a common, hermetically sealed outer housing 44 of
IMD 16. Although cardiac therapy module 104 and neurostimulation
therapy module 106 are illustrated as separate modules in FIG. 4,
in some examples, cardiac therapy module 104 and neurostimulation
module 106 and their respective components may share circuitry. For
example, signal generators 112 and 116 may share common circuitry,
e.g., a stimulation engine, charging circuitry, capacitors, and the
like. As an example, in examples in which cardiac therapy module
104 and neurostimulation module 106 deliver stimulation in
alternation, cardiac therapy module 104 and neurostimulation module
106 may share some or all stimulation generation circuitry.
Similarly, in some examples, sensing modules 114 and 118 may also
share common circuitry, such as an analog-to-digital converters and
the like.
[0092] Memory 102 includes computer-readable instructions that,
when executed by processor 100, cause IMD 16 and processor 100 to
perform various functions attributed to IMD 16 and processor 100
herein. In FIG. 4, memory 102 includes cardiac rhythm management
therapy programs 122 that define the parameters with which cardiac
therapy module 104 generates cardiac rhythm management therapy for
delivery to heart 14, and neurostimulation programs 124 that define
the parameters with which neurostimulation module 106 generates
neurostimulation therapy for delivery to target tissue site 40.
Memory 102 may include any volatile, non-volatile, magnetic,
optical, or electrical media, such as a random access memory (RAM),
read-only memory (ROM), non-volatile RAM (NVRAM),
electrically-erasable programmable ROM (EEPROM), flash memory, or
any other digital media.
[0093] Processor 100 may include any one or more of a
microprocessor, a controller, a digital signal processor (DSP), an
application specific integrated circuit (ASIC), a
field-programmable gate array (FPGA), or equivalent discrete or
integrated logic circuitry. In some examples, processor 100 may
include multiple components, such as any combination of one or more
microprocessors, one or more controllers, one or more DSPs, one or
more ASICs, or one or more FPGAs, as well as other discrete or
integrated logic circuitry. The functions attributed to processor
100 herein may be embodied as software, firmware, hardware or any
combination thereof. Processor 100 may control cardiac therapy
module 104 to deliver stimulation therapy according to a selected
one or more of cardiac rhythm management programs 122 stored in
memory 102. In addition, processor 100 may control neurostimulation
module 106 to delivering stimulation therapy according to a
selected one or more of neurostimulation programs 124 stored in
memory 102. Specifically, processor 100 may control cardiac therapy
module 104 and/or neurostimulation module 106 to deliver electrical
signals with the amplitudes, frequency, electrode polarities, and,
in the case of stimulation pulses, pulse widths specified by the
selected one or more cardiac and neurostimulation therapy programs
122, 124, respectively.
[0094] In the example shown in FIG. 4, cardiac therapy module 104
is electrically connected to electrodes 50, 52, 54, 56, 58, 60, 72,
74, and 76 of leads 18, 20, and 22 and housing electrode 68, and
neurostimulation module 106 is electrically connected to electrodes
80-83 of lead 28 and housing electrode 68. In other examples,
cardiac therapy module 104 and neurostimulation module 106 may be
coupled to any suitable number of electrodes, which may comprise a
greater number of electrodes or a fewer number of electrodes.
[0095] Cardiac therapy module 104 is configured to generate and
deliver cardiac rhythm therapy to heart 14. For example, signal
generator 112 of cardiac therapy module 104 may generate and
deliver cardioversion or defibrillation shocks and/or pacing pulses
to heart 14 via a select combination of electrodes 50, 52, 54, 56,
58, 60, 72, 74, and 76 and housing electrode 68. Stimulation
generator 112 of cardiac therapy module 104 is electrically coupled
to electrodes 50, 52, 54, 56, 58, 60, 72, 74, and 76, e.g., via
conductors of the respective lead 18, 20, 22, or, in the case of
housing electrode 68, via an electrical conductor disposed within
housing 44 of IMD 16. Stimulation generator 112 is configured to
generate and deliver cardiac rhythm management therapy to heart 14.
For example, stimulation generator 112 may deliver defibrillation
shocks to heart 14 via at least two electrodes 68, 72, 74, 76.
Signal generator 112 may deliver pacing pulses via ring electrodes
50, 54, 58 coupled to leads 18, 20, and 22, respectively, and/or
helical electrodes 52, 56, and 60 of leads 18, 20, and 22,
respectively. In some examples, signal generator 112 delivers
pacing, cardioversion, or defibrillation therapy in the form of
electrical pulses. In other examples, signal generator 112 may
deliver one or more of these types of stimulation in the form of
other signals, such as sine waves, square waves, or other
substantially continuous time signals.
[0096] Although not shown in FIG. 4, in some examples, cardiac
therapy module 104 may include a switching module to selectively
couple electrodes 50, 52, 54, 56, 58, 60, 72, 74, and 76 to signal
generator 112 and/or sensing module 114. The switching module may
include a switch array, switch matrix, multiplexer, or any other
type of switching device suitable to selectively couple stimulation
energy to selected electrodes. In other examples, however,
stimulation generator 112 may independently deliver stimulation to
electrodes 50, 52, 54, 56, 58, 60, 72, 74, and 76 or selectively
sense via one or more of electrodes 50, 52, 54, 56, 58, 60, 72, 74,
and 76 without a switch matrix.
[0097] Sensing module 114 monitors signals from at least one of
electrodes 50, 52, 54, 56, 58, 60, 72, 74, and 76 in order to
monitor electrical activity of heart 14, e.g., via an EGM or ECG
signal. In some examples, sensing module 114 includes a switching
module (not shown in FIG. 4) to select a particular subset of
available electrodes to sense the heart activity. Processor 100
may, in some examples, select the electrodes that function as sense
electrodes via the switching module within sensing module 114,
e.g., by providing signals via a data/address bus. In some
examples, sensing module 114 includes one or more sensing channels,
each of which may comprise an amplifier. In response to the signals
from processor 100, the switching module of within sensing module
114 may couple the outputs from the selected electrodes to one of
the sensing channels.
[0098] One channel of sensing module 114 may include an R-wave
amplifier that receives signals from electrodes 50 and 52, which
are used for pacing and sensing in right ventricle 32 of heart 14.
Another channel may include another R-wave amplifier that receives
signals from electrodes 54 and 56, which are used for pacing and
sensing proximate to left ventricle 36 of heart 14. In some
examples, in one operating mode of sensing module 114, the R-wave
amplifiers may take the form of an automatic gain controlled
amplifier that provides an adjustable sensing threshold as a
function of the determined R-wave amplitude of the heart
rhythm.
[0099] In addition, in some examples, one channel of sensing module
114 may include a P-wave amplifier that receives signals from
electrodes 58 and 60, which are used for pacing and sensing in
right atrium 30 of heart 14. In some examples, in one operating
mode of sensing module 114, the P-wave amplifier may take the form
of an automatic gain controlled amplifier that provides an
adjustable sensing threshold as a function of the determined P-wave
amplitude of the heart rhythm. Examples of R-wave and P-wave
amplifiers are described in U.S. Pat. No. 5,117,824 to Keimel et
al., which issued on Jun. 2, 1992 and is entitled, "APPARATUS FOR
MONITORING ELECTRICAL PHYSIOLOGIC SIGNALS," and is incorporated
herein by reference in its entirety. Other amplifiers may also be
used. Furthermore, in some examples, one or more of the sensing
channels of sensing module 114 may be selectively coupled to
housing electrode 68, or elongated electrodes 72, 74, or 76, with
or instead of one or more of electrodes 50, 52, 54, 56, 58 or 60,
e.g., for unipolar sensing of R-waves or P-waves in any of chambers
30, 32, or 36 of heart 14.
[0100] In some examples, sensing module 114 includes a channel that
comprises an amplifier with a relatively wider pass band than the
R-wave or P-wave amplifiers. Signals from the selected sensing
electrodes that are selected for coupling to this wide-band
amplifier may be provided to a multiplexer, and thereafter
converted to multi-bit digital signals by an analog-to-digital
converter for storage in memory 102 as an EGM. In some examples,
the storage of such EGMs in memory 102 may be under the control of
a direct memory access circuit. Processor 100 may employ digital
signal analysis techniques to characterize the digitized signals
stored in memory 102 to detect and classify the patient's heart
rhythm from the electrical signals. Processor 100 may detect and
classify the heart rhythm of patient 12 by employing any of the
numerous signal processing methodologies known in the art.
[0101] If cardiac therapy module 104 is configured to generate and
deliver pacing pulses to heart 14, processor 100 may include pacer
timing and control module, which may be embodied as hardware,
firmware, software, or any combination thereof. The pacer timing
and control module may comprise a dedicated hardware circuit, such
as an ASIC, separate from other processor 100 components, such as a
microprocessor, or a software module executed by a component of
processor 100, which may be a microprocessor or ASIC. The pacer
timing and control module may include programmable counters which
control the basic time intervals associated with DDD, VVI, DVI,
VDD, AAI, DDI, DDDR, VVIR, DVIR, VDDR, AAIR, DDIR and other modes
of single and dual chamber pacing. In the aforementioned pacing
modes, "D" may indicate dual chamber, "V" may indicate a ventricle,
"I" may indicate inhibited pacing (e.g., no pacing), and "A" may
indicate an atrium. The first letter in the pacing mode may
indicate the chamber that is paced, the second letter may indicate
the chamber in which an electrical signal is sensed, and the third
letter may indicate the chamber in which the response to sensing is
provided.
[0102] Intervals defined by the pacer timing and control module
within processor 100 may include atrial and ventricular pacing
escape intervals, refractory periods during which sensed P-waves
and R-waves are ineffective to restart timing of the escape
intervals, and the pulse widths of the pacing pulses. As another
example, the pace timing and control module may define a blanking
period, and provide signals from sensing module 114 to blank one or
more channels, e.g., amplifiers, for a period during and after
delivery of electrical stimulation to heart 14. The durations of
these intervals may be determined by processor 100 in response to
stored data in memory 102. The pacer timing and control module of
processor 100 may also determine the amplitude of the cardiac
pacing pulses.
[0103] During pacing, escape interval counters within the pacer
timing/control module of processor 100 may be reset upon sensing of
R-waves and P-waves. Signal generator 112 may include pacer output
circuits that are coupled, e.g., selectively by a switching module,
to any combination of electrodes 50, 52, 54, 56, 58, 60, 68, 72,
74, and 76 appropriate for delivery of a bipolar or unipolar pacing
pulse to one of the chambers of heart 14. Processor 100 may reset
the escape interval counters upon the generation of pacing pulses
by signal generator 112, and thereby control the basic timing of
cardiac pacing functions, including anti-tachyarrhythmia
pacing.
[0104] The value of the count present in the escape interval
counters when reset by sensed R-waves and P-waves may be used by
processor 100 to determine the durations of R--R intervals, P--P
intervals, P--R intervals and R--P intervals, which are
measurements that may be stored in memory 102. Processor 100 may
use the count in the interval counters to detect a tachyarrhythmia
event, such as ventricular fibrillation event or ventricular
tachycardia event. Upon detecting a threshold number of
tachyarrhythmia events, processor 100 may identify the presence of
a tachyarrhythmia episode, such as a ventricular fibrillation
episode, a ventricular tachycardia episode, or a non-sustained
tachycardia (NST) episode. Examples of tachyarrhythmia episodes
that may qualify for delivery of responsive therapy include a
ventricular fibrillation episode or a ventricular tachyarrhythmia
episode. In the case of a NST, however, the count in the interval
counters may not meet the requirements for triggering a therapeutic
response.
[0105] In some examples, processor 100 may operate as an interrupt
driven device, and is responsive to interrupts from pacer timing
and control module, where the interrupts may correspond to the
occurrences of sensed P-waves and R-waves and the generation of
cardiac pacing pulses. Any necessary mathematical calculations to
be performed by processor 100 and any updating of the values or
intervals controlled by the pacer timing and control module of
processor 100 may take place following such interrupts. A portion
of memory 102 may be configured as a plurality of recirculating
buffers, capable of holding series of measured intervals, which may
be analyzed by processor 100 in response to the occurrence of a
pace or sense interrupt to determine whether heart 14 of patient 12
is presently exhibiting atrial or ventricular tachyarrhythmia.
[0106] In some examples, an arrhythmia detection method may include
any suitable tachyarrhythmia detection algorithms. In one example,
processor 100 may utilize all or a subset of the rule-based
detection methods described in U.S. Pat. No. 5,545,186 to Olson et
al., entitled, "PRIORITIZED RULE BASED METHOD AND APPARATUS FOR
DIAGNOSIS AND TREATMENT OF ARRHYTHMIAS," which issued on Aug. 13,
1996, or in U.S. Pat. No. 5,755,736 to Gillberg et al., entitled,
"PRIORITIZED RULE BASED METHOD AND APPARATUS FOR DIAGNOSIS AND
TREATMENT OF ARRHYTHMIAS," which issued on May 26, 1998. U.S. Pat.
No. 5,545,186 to Olson et al. and U.S. Pat. No. 5,755,736 to
Gillberg et al. are incorporated herein by reference in their
entireties. However, other arrhythmia detection methodologies may
also be employed by processor 100 in other examples.
[0107] In the examples described herein, processor 100 may identify
the presence of an atrial or ventricular tachyarrhythmia episode by
detecting a series of tachyarrhythmia events (e.g., R--R or P--P
intervals having a duration less than or equal to a threshold) of
an average rate indicative of tachyarrhythmia or an unbroken series
of short R--R or P--P intervals. The thresholds for determining the
R--R or P--P interval that indicates a tachyarrhythmia event may be
stored within memory 102 of IMD 16. In addition, the number of
tachyarrhythmia events that are detected to confirm the presence of
a tachyarrhythmia episode may be stored as a number of intervals to
detect (NID) threshold value in memory 102. In some examples,
processor 100 may also identify the presence of the tachyarrhythmia
episode by detecting a variability of the intervals between
tachycardia events. For example, if the interval between successive
tachyarrhythmia events varies by a particular percentage or the
differences between the coupling intervals are higher than a given
threshold over a predetermined number of successive cycles,
processor 100 may determine that the tachyarrhythmia is
present.
[0108] If processor 100 detects an atrial or ventricular
tachyarrhythmia based on signals from sensing module 114, and an
anti-tachyarrhythmia pacing regimen is desired, timing intervals
for controlling the generation of anti-tachyarrhythmia pacing
therapies by signal generator 112 may be loaded by processor 100
into the pacer timing and control module to control the operation
of the escape interval counters therein and to define refractory
periods during which detection of R-waves and P-waves is
ineffective to restart the escape interval counters.
[0109] If cardiac therapy module 104 is configured to generate and
deliver defibrillation pulses to heart 14, signal generator 112 may
include a high voltage charge circuit and a high voltage output
circuit. In the event that generation of a cardioversion or
defibrillation pulse is required, processor 100 may employ the
escape interval counter to control timing of such cardioversion and
defibrillation pulses, as well as associated refractory periods. In
response to the detection of atrial or ventricular fibrillation or
tachyarrhythmia requiring a cardioversion pulse, processor 100 may
activate a cardioversion/defibrillation control module, which may,
like pacer timing and control module, be a hardware component of
processor 100 and/or a firmware or software module executed by one
or more hardware components of processor 100. The
cardioversion/defibrillation control module may initiate charging
of the high voltage capacitors of the high voltage charge circuit
of signal generator 112 under control of a high voltage charging
control line.
[0110] Processor 100 may monitor the voltage on the high voltage
capacitor, e.g., via a voltage charging and potential (VCAP) line.
In response to the voltage on the high voltage capacitor reaching a
predetermined value set by processor 100, processor 100 may
generate a logic signal that terminates charging. Thereafter,
timing of the delivery of the defibrillation or cardioversion pulse
by signal generator 112 is controlled by the
cardioversion/defibrillation control module of processor 100.
Following delivery of the fibrillation or tachycardia therapy,
processor 100 may return signal generator 112 to a cardiac pacing
function and await the next successive interrupt due to pacing or
the occurrence of a sensed atrial or ventricular
depolarization.
[0111] Signal generator 112 may deliver cardioversion or
defibrillation pulses with the aid of an output circuit that
determines whether a monophasic or biphasic pulse is delivered,
whether housing electrode 68 serves as cathode or anode, and which
electrodes are involved in delivery of the cardioversion or
defibrillation pulses. Such functionality may be provided by one or
more switches or a switching module of signal generator 112.
[0112] Neurostimulation module 106 is configured to generate and
deliver electrical stimulation therapy to a tissue site proximate a
nerve or a nonmyocardial or extravascular cardiac tissue site,
e.g., in order to modulate an autonomic nervous system or modulate
vascular tone. Example stimulation sites for neurostimulation
module 106 include, but are not limited to, tissue proximate a
vagus nerve, braches of vagus nerve, or spinal cord of patient 12.
For example, signal generator 116 may generate stimulation signals
that are delivered to a tissue site proximate a vagus nerve via a
select combination of electrodes 80-83 of lead 28 and/or housing
electrode 68. The stimulation signals may be pulses as primarily
described herein, or continuous time signals, such as sine
waves.
[0113] Signal generator 116 may be a single or multi-channel signal
generator. In particular, signal generator 116 may be capable of
delivering, a single stimulation pulse, multiple stimulation
pulses, or a continuous signal at a given time via a single
electrode combination or multiple stimulation pulses at a given
time via multiple electrode combinations. In some examples,
however, neurostimulation therapy module 106 may be configured to
deliver multiple channels on a time-interleaved basis. In this
case, neurostimulation therapy module 106 may include a switching
module (not shown) that serves to time division multiplex the
output of the signal generator across different electrode
combinations at different times to deliver multiple programs or
channels of stimulation energy to patient 12.
[0114] Although not shown in FIG. 4, in some examples,
neurostimulation therapy module 106 may include a switching module
to selectively couple electrodes 68, 80-83 to signal generator 116
and/or sensing module 118. The switching module may couple
stimulation signals to selected conductors within lead 28, which,
in turn, deliver the stimulation signals across selected
electrodes. The switching module may be a switch array, switch
matrix, multiplexer, or any other type of switching device suitable
to selectively couple stimulation energy to selected
electrodes.
[0115] Processor 100 may control cardiac therapy module 104 and
neurostimulation therapy module 106 to coordinate the delivery of
electrical stimulation to patient 12. As previously described, in
some examples, neurostimulation therapy module 106 may deliver
neurostimulation signals to patient 12 at substantially the same
time as pacing, cardioversion, and/or defibrillation pulses
delivered by cardiac therapy module 104. In those examples,
processor 100 may control cardiac therapy module 104 and
neurostimulation module 106 to generate and deliver electrical
stimulation at substantially the same time.
[0116] In other examples, in addition to or instead of delivering
neurostimulation signals at substantially the same time that
cardiac therapy module 104 delivers stimulation, neurostimulation
module 106 may deliver neurostimulation signals to patient 12 prior
to or after cardiac therapy module 104 delivers stimulation. Thus,
in some examples, processor 100 may control cardiac therapy module
104 and neurostimulation therapy module 106 to deliver therapy to
patient 12 at different times. In some examples, processor 100 may
control neurostimulation module 106 to deliver neurostimulation
signals to patient 12 based on physiological parameter values
sensed by sensing module 114 of cardiac therapy module 104 of
sensing module 118 of neurostimulation therapy module 160, which
may indicate the presence of an arrhythmia.
[0117] In other examples, processor 100 may control
neurostimulation therapy module 106 to deliver neurostimulation
signals to patient 12 according to a predetermined schedule that is
independent of physiological parameter values sensed by sensing
module 114. The schedule may be determined by a clinician and
stored in memory 102. As previously indicated, the delivery of
electrical stimulation by neurostimulation module 106 to modulate
an autonomic system of the patient's nervous system may help
regulate the patient's heart rate. Thus, processor 100 may control
neurostimulation module 106 to generate and deliver
neurostimulation signals to patient 12 as a preventative measure,
e.g., to reduce the occurrence of arrhythmias, and, therefore,
reduce the frequency with which cardiac therapy module 104 generate
and delivers stimulation.
[0118] Telemetry module 108 includes any suitable hardware,
firmware, software or any combination thereof for communicating
with another device, such as programmer 24 (FIG. 1). Under the
control of processor 100, telemetry module 108 may receive downlink
telemetry from and send uplink telemetry to programmer 24 with the
aid of an antenna, which may be internal and/or external. Processor
100 may provide the data to be uplinked to programmer 24 and the
control signals for the telemetry circuit within telemetry module
108, e.g., via an address/data bus. In some examples, telemetry
module 108 may provide received data to processor 100 via a
multiplexer.
[0119] In some examples, processor 100 may transmit atrial and
ventricular heart signals (e.g., also referred to as cardiac
signals, and can include, for example, EGM signals) produced by
sensing module 114 to programmer 24. In some examples, programmer
24 interrogates IMD 16 to retrieve the heart signals, while in
other examples, IMD 16 automatically transmits the heart signals to
programmer 24. Processor 100 may store heart signals within memory
102, and retrieve stored heart signals from memory 102. Processor
100 may also generate and store marker codes indicative of
different cardiac episodes that sensing module 114 detects, and
transmit the marker codes to programmer 24. An example pacemaker
with marker-channel capability is described in U.S. Pat. No.
4,374,382 to Markowitz, entitled, "MARKER CHANNEL TELEMETRY SYSTEM
FOR A MEDICAL DEVICE," which issued on Feb. 15, 1983 and is
incorporated herein by reference in its entirety.
[0120] Processor 100 may also control telemetry module 108 to
transmit an alert signal to programmer 24 when processor 100
determines that lead 28 has migrated from target tissue site 40.
That is, when IMD 16 determines that lead 28 has migrated from
target tissue site 40, processor 100 may withhold delivery of
stimulation by neurostimulation module 106 and cause telemetry
module 108 to transmit an alert signal to programmer 24. Programmer
24 may display a message via a monitor that alerts the user that
lead 28 has migrated from target tissue site 40 and that
neurostimulation is suspended. Programmer 24 may also generate an
audible or tactile alert in response to receiving the alert
message/signal from IMD 16.
[0121] The various components of IMD 16 are coupled to power source
100, which may include a rechargeable or non-rechargeable battery
or a supercapacitor. A non-rechargeable battery may be selected to
last for several years, while a rechargeable battery may be
inductively charged from an external device, e.g., on a daily or
weekly basis.
[0122] In some examples, data generated by sensing module 114 or
sensing module 118 and stored in memory 102 may be uploaded to a
remote server, from which a clinician or another user may access
the data to determine whether a potential lead migration issue
exists. An example of a remote server includes the CareLink
Network, available from Medtronic, Inc. of Minneapolis, Minn. An
example system may include an external device, such as a server,
and one or more computing devices that are coupled to IMD 16 and
programmer 24 via a network.
[0123] In accordance with various examples described in this
disclosure, processor 100 of IMD 16 may implement one or more of
the previously described techniques in order to determine whether
neurostimulation should be withheld from patient 12 or otherwise
modified because electrodes 80-83 of lead 28 have migrated from
target tissue site 40 and toward heart 14. IMD 16 may periodically
or substantially continuously monitor the relative location of
electrodes 80-83 of lead 28 and target tissue site 40 (or heart
14). For example, IMD 16 may perform one or more of the lead
migration detection techniques according to a schedule stored in
memory 102. The schedule may cause IMD 16 to execute the migration
detection technique on a daily basis, an hourly basis, or several
times per day, such as approximately every twenty minutes, fifteen
minutes, ten minutes, five minutes, or approximately every minute.
Alternatively, IMD 16 may continuously repeat one or more of the
migration detection techniques. Other frequencies with which IMD 16
may determine whether electrodes 80-83 of lead 28 have moved are
also contemplated.
[0124] In the example shown in FIG. 4, processor 100 includes lead
migration detection module 120, which may be implemented with a
dedicated processor, logic circuitry, or may be part of processor
100, such as dedicated firmware. In operation, lead migration
detection module 120 controls operation of and process information
received from one or more of cardiac therapy module 104 and
neurostimulation therapy module 106. As one example, lead migration
detection module 120 may control operation of neurostimulation
therapy module 106 to determine whether lead 28 has migrated to the
extent that there is loss of nerve capture by electrodes 80-83. In
accordance with the techniques implemented by lead migration
detection module 120, which are described below, lead migration
detection module 120 may include filters, comparators, correlators
(matched filters), analog-to-digital converters (ADCs),
sample-and-hold circuitry, or other signal processing and/or logic
circuitry for analyzing sensed electrical signals, near field
cardiac signals (e.g., ECG or EGM signals), and far field cardiac
signals (ECG or EGM signals).
[0125] Lead migration detection module 120 may control signal
generator 116 to generate and deliver a test electrical stimulation
signal to patient 12 via one or more of electrodes 80-83 of lead
28. For example, lead migration detection module 120 may control
signal generator 116 to deliver the test signal prior to delivering
neurostimulation to patient 12 in order to determine whether
electrodes 80-83 are at least a predetermined distance away from
heart 14. The predetermined distance can be, for example, a minimum
distance at which electrical stimulation delivered via electrodes
80-83 does not capture heart 14. In this way, the predetermined
distance can indicate a relative location of electrodes 80-83
relative to heart 14. As discussed above, a physiological response
to the test signal may indicate whether electrodes 80-83 are at
least the predetermined distance away from heart 14. In some
examples, lead migration detection module 120 may generate a test
electrical stimulation signal with electrodes 80,81, which are
located closer to a distal tip of lead 28 than electrodes 82,83,
and, in some cases, may provide a better indication of whether
electrodes 80-83 have migrated toward heart 14 because electrodes
80,81 may be closer to heart 14 than electrodes 82,83 when lead 28
migrates.
[0126] Lead migration detection module 120 may also control signal
generator 116 to deliver a test signal via the electrodes located
at the most distal end of lead 28, i.e., electrodes 80 and 81
(FIGS. 2 and 3). The test electrical stimulation signal may be a
single pulse or other pulse waveform or continuous signal. In some
examples, lead migration detection module 120 controls signal
generator 116 to deliver the test signal during the ventricular
refractory period. In other words, the test signal may be coupled
to an R-wave. For example, the test stimulation signal waveform may
have a relatively low frequency, such as a frequency of about 1 Hz.
The test stimulation signal may or may not provide therapeutic
benefits to patient 12. The stimulation parameter values for the
test stimulation signal may be stored as a neurostimulation program
124 in memory 102. Lead migration detection module 120 may then
control sensing module 118 to sense an electrical signal indicative
of a physiological response to the stimulation signal, and analyze
the sensed electrical signal provided by sensing module 118. If
lead migration detection module 120 determines the physiological
response (e.g., as indicated by the sensed electrical signal)
indicates there is loss of nerve capture, lead migration detection
module 120 may control neurostimulation therapy module 106 and,
more particularly, stimulation module 116, to suspend the delivery
of neurostimulation to patient 12 or otherwise adjust the delivery
of neurostimulation therapy to patient 12 (e.g., adjust a
stimulation parameter, such as a frequency, amplitude, pulse width,
and the like to decrease the possibility that a neurostimulation
signal will capture heart 14).
[0127] In some examples, sensing module 118 may sense an electrical
nerve signal between two or more of electrodes 80-83 and output the
electrical nerve signal to lead migration detection module 120. The
electrical nerve signal may be an electrical signal generated by a
vagus nerve in response to the delivery of the test electrical
stimulation signal by signal generator 116. The electrical nerve
signal may indicate whether lead 28 has migrated away from target
tissue site 40, which may, in turn, indicate whether lead 28 has
migrated towards heart 14. An example electrical nerve signal is
shown and described with respect to FIG. 7. In some examples, the
electrical nerve signal may be an electroneurogram (ENG) that is
generated by sensing module 118. An ENG may indicate the electrical
activity of neurons of the vagus nerve (or other target nerve for
the neurostimulation therapy).
[0128] If the test electrical stimulation delivered by signal
generator 116 captures the vagus nerve, the electrical nerve signal
generated by the vagus nerve may indicate the physiological
response to the test stimulation signal. In some examples, lead
migration detection module 120 may determine whether the vagus
nerve was captured by the test stimulation signal by measuring an
amplitude of the electrical nerve signal and comparing the
determined amplitude value to a predetermined threshold value
stored in memory 102. A determined amplitude value of the sensed
electrical nerve signal that is less than the threshold value may
indicate a loss of nerve capture by electrodes 80-83 of lead 28.
The loss of nerve capture may be a result of migration of
electrodes 80-83 from target tissue site 40 (FIG. 1). As previously
described, lead migration detection module 120 may control
neurostimulation module 106 to withhold the delivery of
neurostimulation to patient 12 or otherwise adjust the
neurostimulation therapy parameters when a loss of nerve capture is
detected. The loss of nerve capture may indicate that electrodes
80-83 have migrated toward heart 14.
[0129] In other examples, sensing module 118 may sense a
physiological response to the test stimulation signal delivered by
signal generator 116 of neurostimulation module 106 by sensing
movement (e.g., vibrations or contraction) of muscle that is
proximate target tissue site 40 (FIG. 1). The muscle may be
stimulated by the test stimulation signal because of the proximity
of the muscle to electrodes 80-83 on lead 28 or because the muscle
is innervated by the target nerve (e.g., vagus nerve), which is
stimulated by the test stimulation signal. In some examples,
sensing module 118 may sense vibrations generated by laryngeal
muscle tissue proximate to target tissue site 40. Sensing module
118 may be electrically connected to a sensor that that generates
an electrical signal indicative of the muscle movement, such as a
pressure sensor, an acoustic sensor, an accelerometer,
piezoelectric sensor, and the like. The sensor indicative of muscle
movement may be on lead 28 or another lead. Alternatively, the
pressure sensor, acoustic sensor, accelerometer, or piezoelectric
sensor may be located within housing 44 of IMD 16 and electrically
coupled to sensing module 118, or may be a separately implanted
sensor that communicates with IMD 16. In some examples, sensing
module 118 may generate an EMG, which indicates the electrical
potential generated by muscle cells when the cells contract.
[0130] Sensing module 118 may output the sensed electrical signal
indicative of muscle movement to lead migration detection module
120. Lead migration detection module 120 may analyze the sensed
electrical signal to determine whether a characteristic of the
signal indicates the loss of nerve capture. If electrodes 80-83 are
located proximate the target nerve, the delivery of the test
stimulation signal may capture the target nerve, and the muscle
innervated by the target nerve may move in response to the delivery
of the test stimulation signal. Thus, if the characteristic of the
sensed electrical muscle signal indicates a low level of muscle
movement, the electrical muscle signal may indicate the loss of
nerve capture. Loss of nerve capture (e.g., a decrease in nerve
capture or a complete loss of nerve capture) by the stimulation
delivered by neurostimulation therapy module 106 may indicate that
neurostimulation lead 28 has migrated from target tissue site
40.
[0131] Lead migration detection module 120 may compare the
characteristic of the sensed electrical muscle signal to a
threshold value stored within memory 102 to determine whether the
sensed electrical signal is indicative of an expected physiological
response to the test stimulation signal when electrodes 80-83 are
located within a sufficient distance to the target nerve, e.g., at
target tissue site 40. If the characteristic of the sensed
electrical muscle signal is less than or equal to the threshold
value, lead migration detection module 120 may determine that
electrodes 80-83 of lead 28 have moved and there is a loss of nerve
capture. Thus, if the characteristic of the sensed electrical
muscle signal is less than or equal to the threshold value,
processor 100 may control neurostimulation therapy module 106 to
suspend or otherwise adjust the delivery of stimulation to patient
12.
[0132] In some examples, the characteristic of the sensed
electrical muscle signal may include a frequency or amplitude of
the electrical signal. Lead migration detection module 120 may
determine the frequency of sensed electrical muscle signal by
applying an analog-to-digital converter (ADC) and performing a Fast
Fourier Transform (FFT) on the digital signal. Alternatively, lead
migration detection module 120 may use a peak amplitude detector to
determine the number of amplitude peaks over a given time period
and, thus, the frequency of the sensed electrical signal. In any
case, the frequency of the signal may change as the distance
between the laryngeal muscle tissue and lead 28 increases.
Accordingly, in some examples, lead migration detection module 120
may control neurostimulation module 106 to withhold the delivery of
neurostimulation to patient 12 or otherwise adjust neurostimulation
therapy based on the comparison of the determined frequency to a
threshold frequency stored in memory 102.
[0133] Cardiac capture is another physiological response that lead
migration detection module 120 may monitor for following the
delivery of the test stimulation signal by signal generator 116 in
order to determine whether electrodes 80-83 have migrated away from
target tissue site 40 and toward heart 14. Lead migration detection
module 120 may control operation of neurostimulation module 106 to
determine whether there is cardiac capture. When lead migration
detection module 120 determines that there is cardiac capture, lead
migration detection module 120 may control neurostimulation module
106 to withhold or otherwise adjust the delivery of delivering
neurostimulation to patient 12 because the cardiac capture may
indicate electrodes 80-83 have migrated toward heart 14.
[0134] As described above with respect to the technique for
detecting loss of nerve capture, lead migration detection module
120 may cause signal generator 116 to deliver a test electrical
stimulation signal to target tissue site 40 via a select
combination of electrodes 80-83 of lead 28. In some examples, the
test stimulation signal may comprise a frequency of about 1 Hz and
an amplitude of about 8 volts (V). In some examples, the voltage or
current amplitude of the test signal may be greater than the
planned voltage or current amplitude value for therapy to provide a
guard band.
[0135] Instead of or in addition to detecting a signal indicative
of nerve capture, lead migration detection module 120 may detect an
electrical cardiac signal indicative of cardiac activity of heart
14 in response to the delivery of the test electrical signal. The
cardiac signal may comprise, for example, an ECG or EGM signal
generated by sensing module 114 of cardiac therapy module 104 or
sensing module 118 of neurostimulation therapy module 106. Sensing
module 114 may generate a (near) field cardiac signal (e.g., a near
field ECG or EGM signal) under the control of lead migration
detection module 120 for a period of time following delivery of the
test stimulation pulse by signal generator 116. In particular,
sensing module 114 may sense the cardiac signal via select
electrodes of leads 18, 20, and 22. Lead migration detection module
120 may analyze the sensed cardiac signal to detect a physiological
response, e.g., an evoked response, to the test stimulation signal
delivered by signal generator 116.
[0136] The response by heart 14 evoked by the delivery of the test
stimulation signal (the "evoked response") may take various forms.
For this reason, a clinician may determine one or more
characteristics of a sensed cardiac signal that indicate the evoked
response caused by lead 28 migrating from target tissue site 40
during a trial stage, such as during implantation of therapy system
10 in patient 12. As an example, the clinician may position lead 28
proximate heart 14 and deliver test stimulation signals via signal
generator 116. The clinician may then sense a cardiac signal with a
select combination of electrodes of leads 18, 20, 22, and 28 to
determine one or more characteristics of the cardiac signal that
indicate the test stimulation signals captured heart 14, e.g.,
paced heart 14. The characteristic of the sensed cardiac signal
that indicates cardiac capture by the test stimulation signal may
indicate, for example, depolarization artifacts that follow the
delivery of the test stimulation signal. The depolarization
artifacts present in the sensed cardiac signal may include, for
example, an R-wave, a P-wave or other components of a QRS complex
of a sinus rhythm of heart 14.
[0137] Lead migration detection module 120 may be configured to
process the (near field) cardiac signal to detect the evoked
response to the test stimulation signal. An example evoked response
may take the form of a normal cardiac waveform (P-wave, QRS
complex, and T-wave) that appears within a certain period of time
following delivery of the stimulation pulse. Other examples of an
evoked response may include a P-wave or a P-wave followed by some
irregular waveform, an R-wave, or some other irregular amplitude
peak. An example cardiac signal with an evoked response is show and
described with respect to FIG. 8.
[0138] Lead migration detection module 120 may analyze the cardiac
signal to detect an evoked response by, for example, measuring an
amplitude of the cardiac signal and comparing the determined
amplitude to a threshold value stored in memory 102. The amplitude
may be, for example, a mean or median amplitude. In other examples,
lead migration detection module 120 may detect an amplitude spike
following the delivery of the test stimulation signal by signal
generator 116. In yet other examples, lead migration detection
module 120 may correlate the cardiac signal sensed following the
delivery of the test stimulation signal with values stored in a
memory 102 and compare the correlation value to a threshold value.
The values may indicate, for example, a waveform of a sinus rhythm.
For each example detection method, lead migration detection module
120 may analyze the cardiac signal over a period of time following
delivery of the test stimulation signal. The period of time may be
selected so as to substantially avoid detecting a normal cardiac
waveform as an evoked response to the test stimulation delivered by
neurostimulation module 106 to determine whether lead 28 has
migrated from target tissue site 40.
[0139] In some examples, lead migration detection module 120 may
determine whether electrodes 80-83 of neurostimulation lead 28 have
migrated toward heart 14 based on a far field cardiac signal (e.g.,
an ECG or EGM) sensed by sensing module 118 of neurostimulation
therapy module 106 via a subset of electrodes 80-83 of
neurostimulation lead 28. Because the amplitude of the far field
cardiac signal may decrease as the distance between heart 14 and
neurostimulation electrodes 80-83 of lead 28 increases, lead
migration detection module 120 may analyze the far field ECG or EGM
signal to determine whether the position of lead 28 relative to
heart 14 indicates the withholding of neurostimulation therapy or
other adjustment to neurostimulation therapy is desirable. In one
example, lead migration detection module 120 may analyze the far
field cardiac signal by measuring an amplitude of the far field
cardiac signal and comparing the amplitude to a threshold value
stored in memory 102. The predetermined and stored threshold
amplitude value may indicate the maximum amplitude value that
indicates electrodes 80-83 are at least a predetermined distance
from heart 14. The predetermined distance may be, for example, a
minimum distance away from heart 14 at which the delivery of
neurostimulation to patient 12 via electrodes 80-83 does not
capture heart 14. Thus, if the determined amplitude value is
greater than or equal to the threshold value, lead migration
detection module 120 may control neurostimulation module 106 to
suspend or otherwise adjust the delivery of neurostimulation to
patient 12. In other examples, lead migration detection module 120
may determine the polarity, morphology, or frequency content of the
ECG or EGM signal and selectively withhold delivery of
neurostimulation to patient 12 based on a comparison of the
determined value to a corresponding threshold value.
[0140] Additionally or alternatively, lead migration detection
module 120 may analyze the far field cardiac signal by measuring a
change in amplitude, polarity, morphology, or frequency content
over time. As an example, lead migration detection module 120 may
track the position of lead 28 relative to heart 14 based on the
change in amplitude of the far field cardiac signal. A sudden
change in amplitude of the far field cardiac signal, as indicated
by an abrupt change in amplitude over time (e.g., a large slope)
may indicate neurostimulation electrodes 80-83 of lead 28 have
migrated toward heart 14. Thus, in some examples, if the change in
amplitude over time is greater than or equal to a threshold slope
value stored in memory 102, lead migration detection module 120 may
control neurostimulation module 106 to suspend or otherwise adjust
the delivery of neurostimulation to patient 12.
[0141] In an additional example, lead migration detection module
120 may analyze the far field cardiac signal by detecting the
presence of one or both of a P-wave and an R-wave in the far field
electrical cardiac signal. When lead 28 is located at target tissue
site 40, the far field signal may include both a P-wave and an
R-wave, and the ratio of the size of the P-wave to the R-wave may
be used to determine a threshold value that indicates lead 28 is
located at target tissue site 40. The size of the P-wave and R-wave
may be determined by measuring an amplitude or by integrating the
respective signal components. The ratio value may change when lead
28 migrates from target tissue site 40. For example, the ratio
value may increase if lead 28 migrates into right atrium 30 (FIG.
1) and the ratio value may decrease if lead 28 migrates in right
ventricle 32 (FIG. 1). Thus, lead migration detection module 120
may analyze the far field ECG or EGM signal to determine the ratio
value and selectively withhold or otherwise adjust the delivery of
neurostimulation to patient 12 based on the comparison of the ratio
value to a threshold value or range of values. In particular, a
range of values may be bounded by a maximum value and a minimum
value. When the determined ratio value is greater than the maximum
value or less than the minimum value, lead migration detection
module 120 may withhold delivery or otherwise adjust the delivery
of neurostimulation to patient 12.
[0142] In another example, IMD 16 may compare or correlate the far
field cardiac signal with a near field cardiac signal sensed by
sensing module 114 of cardiac therapy module 104 via a subset of
electrodes 50, 52, 54, 56, 58, 60, 72, 74, and 76 of cardiac
therapy leads 18, 20, 22. In this example, lead migration detection
module 120 may compare an amplitude of the near field and far field
cardiac signals or correlate a portion of the near field and far
field cardiac signals with each other. The near field cardiac
signal sensed by sensing module 114 of cardiac therapy module 104
may generally comprise a higher amplitude than the far field
cardiac signal because of the proximity of cardiac therapy
electrodes 50, 52, 54, 56, 58, 60, 72, 74, and 76 to heart 14.
[0143] When lead migration detection module 120 compares the near
field and far field signals to determine whether neurostimulation
electrodes 80-83 of lead 28 have migrated toward heart 14, the
amplitude of the far field cardiac signal may be subtracted from
the amplitude of the near field cardiac signal to determine a
difference value. The difference amplitude value may be compared to
a threshold amplitude value stored in memory 102 to determine
whether the position of neurostimulation electrodes 80-83 relative
to heart 14 indicates lead 28, and, therefore, neurostimulation
electrodes 80-83 have migrated toward heart 14. Similarly, lead
migration detection module 120 may compare a correlation value for
the near field and far field signals to a threshold value. The
correlation value may indicate the extent to which the amplitudes
of the near field and far field cardiac signals match. If the
difference threshold value is less than the stored threshold value
or the correlation value is higher than a correlation threshold
value, lead migration detection module 120 may control
neurostimulation module 120 to withhold or otherwise adjust the
delivery of neurostimulation to patient 12.
[0144] Lead migration detection module 120 may also provide
additional or alternative techniques to those described in the
previous paragraphs, e.g., detecting loss of nerve and/or muscle
capture, detecting cardiac capture, and analyzing far field cardiac
signals, to detect migration of neurostimulation lead 28. For
example, lead migration detection module 120 may determine an
electrical parameter value indicative of an impedance of an
electrical path between the electrodes of one or more of leads 18,
20, and 22 and one or more electrodes of lead 28 to detect
migration of lead 28 from the implant site. For example, lead
migration detection module 120 may control signal generator 112 of
cardiac therapy module 104 to transmit an electrical signal across
two or more electrodes of leads 18, 20, and 22 and 80-83 and
sensing module 118 may sense the electrical signal via one or more
electrodes of lead 28. In some examples, housing electrode 68 may
also be used to determine the impedance. The electrical signal may
provide therapeutic benefits to patient 12 or may not provide
therapeutic benefits to patient 12. IMD 16 may utilize a bipolar,
tripolar, or quadrapolar electrode configuration to determine the
impedance of an electrical path between one or more electrodes of
cardiac leads 18, 20, and 22 and one or more electrodes of
neurostimulation lead 28.
[0145] In examples in which lead migration detection module 120
uses a quadrapolar configuration to determine the impedance between
one or more cardiac therapy electrodes 50, 52, 54, 56, 58, 60, 72,
74, and 76 and one or more neurostimulation therapy electrodes
80-83, signal generator 112 of cardiac therapy module 104 may
transmit an electrical signal across two electrodes 50, 52, 54, 56,
58, 60, 72, 74, and 76 of leads 18, 20, and 22 and sensing module
118 of neurostimulation therapy module 106 may sense the electrical
signal using two electrodes 80-83 of lead 28. Because cardiac leads
18, 20, and 22 and neurostimulation lead 28 are implanted at
separate locations within the body of patient 12, neurostimulation
therapy module 106 may sense and electrical signal that has
transmitted across an electrical path between the electrodes of
cardiac lead(s) and the electrodes neurostimulation lead. In this
way, lead migration detection module 120 may determine the
resulting voltage or current of the sensed signal and use the
determined value to determine an impedance value.
[0146] In other examples, signal generator 116 of neurostimulation
therapy module 106 may transmit an electrical signal using two or
more neurostimulation electrodes 80-83 of lead 28 and sensing
module 114 of cardiac therapy module 104 may sense the electrical
signal via electrodes of leads 18, 20, 22. In either example, lead
migration detection module 120 may compare the determined impedance
value to a threshold impedance value stored in memory 102 to
determine whether lead 28 have migrated. The determined impedance
value may indicate whether electrodes 80-83 of lead 28 have
migrated towards heart 14. As electrodes 80-83 of lead 28 move
closer to heart 14, the distance between electrodes 80-83 of lead
28 and electrodes 50, 52, 54, 56, 58, 60, 72, 74, and 76 of leads
18, 20, 22 and housing electrode 68 may decrease. Accordingly, as
electrodes 80-83 of lead 28 move closer to heart 14, an impedance
of the electrical path between electrodes 80-83 of lead 28 and
electrodes 50, 52, 54, 56, 58, 60, 72, 74, and 76 of leads 18, 20,
22 and housing electrode 68 may decrease. Thus, lead migration
detection module 120 may determine that electrodes 80-83 of lead 28
have migrated towards heart 14 if the determined impedance value of
the electrical path between electrodes 80-83 of lead 28 and
electrodes 50, 52, 54, 56, 58, 60, 72, 74, and 76 of leads 18, 20,
22 and housing electrode 68 is less than the threshold impedance
value. If the determined impedance value is less than the stored
threshold impedance value, lead migration detection module 120 may
control neurostimulation therapy module 120 to withhold the
delivery of neurostimulation to patient 12.
[0147] In general, lead migration detection module 120 may control
neurostimulation therapy module 106 to suspend or otherwise adjust
the delivery of neurostimulation to patient 12 using any suitable
technique. While suspension of neurostimulation is primarily
referred to herein, lead migration detection module 120 may also
control neurostimulation therapy module 106 to modify one or more
neurostimulation parameter values, such as an amplitude, frequency,
pulse width, duty cycle, and the like. Thus, the techniques
described herein that relate to suspension of neurostimulation
therapy may also apply to the adjustment of one or more
neurostimulation parameters and the delivery of neurostimulation
according to the adjusted neurostimulation parameters.
[0148] In some examples, in order to suspend the delivery of
neurostimulation, lead migration detection module 120 may generate
an interference indication that indicates that lead 28 has migrated
within patient 12 and that further delivery of neurostimulation to
patient 12 via electrodes 80-83 of lead 28 may be undesirable.
Based on the generation of the interference indication,
neurostimulation therapy module 106 may withhold any further
generation of neurostimulation until user input is received, e.g.,
resetting the interference indication. Processor 100 of IMD 16 may
transmit the interference indication to programmer 24 to alert a
user that lead 28 may have migrated and/or that neurostimulation
therapy has been suspended and medical attention is recommended.
Programmer 24 may display a visual message (e.g., text or
graphics), audible message or somatosensory alert that indicates
neurostimulation has been suspended and, in some examples,
additional information, such as a code that provides information
about the suspension. Lead migration detection module 120 may
alternatively or additionally cause IMD 16 to generate an alert
that may be detected by patient 12. The alert may be an audible
alert, such as a beeping sound, or a somatosensory alert, such as a
vibration emitted by IMD 16.
[0149] Following the suspension of neurostimulation therapy,
programmer 24 send a signal to IMD 16 that causes IMD 16 to revert
back to executing therapy programs that include neurostimulation.
For example, a user (e.g., patient 12 or clinician) may provide
input to programmer 24 in order to instruct IMD 16 to revert back
to executing therapy programs that include neurostimulation. In
some examples, IMD 16 may also automatically revert back to
executing a therapy program that includes neurostimulation when IMD
16 determines that delivering neurostimulation therapy to patient
12 will not be likely to capture heart 14 or interfere with the
sensing of electrical cardiac signals and/or delivery of therapy by
cardiac therapy module 104. In other examples, a clinician may
interact with programmer 24 to restart the delivery of
neurostimulation to patient 12 via neurostimulation therapy module
106, e.g., after evaluating the position of lead 28 and/or
repositioning lead 28. The clinician may evaluate the position of
lead 28 by, for example, any suitable medical imaging technique,
such as fluoroscopy, x-ray imaging, MM, or ultrasound imaging, to
determine the location of lead 28. Lead 28 may include a
radiographic marker for identification purposes during an imaging
procedure.
[0150] FIG. 5 is a functional block diagram illustrating lead
migration detection module 120 of IMD 16 in greater detail. In the
example illustrated in FIG. 5, lead migration detection module 120
includes nerve capture module 122, cardiac capture module 124, far
field cardiac signal module 126, and impedance module 128. Although
FIG. 5 illustrates lead migration detection module 120 as including
each of the modules, in other examples lead migration detection
module 120 may include any number of the modules. In general, the
purpose of FIG. 5 is to illustrate a logical relationship between
the various features provided by lead migration detection module
120 and the cardiac therapy and neurostimulation modules 104 and
106, respectively.
[0151] In the illustrated example of FIG. 5, a signal path 121 is
shown. Lead migration detection module 120 may use signal path 121
to transmit information to neurostimulation module 106. For
example, lead migration detection module 120 may transmit a control
signal to neurostimulation module 106 via signal path 121, where
the signal may control neurostimulation module 106 to withhold or
otherwise adjust the generation and delivery of neurostimulation to
patient 12. Thus, when any of modules 122, 124, 126, or 128
determine that delivery of neurostimulation to patient 12 is
undesirable, the respective module 122, 124, 126, or 128 may send a
control signal to neurostimulation module 106 via signal path 121.
The modules 122, 124, 126, or 128 may determine that
neurostimulation is undesirable, for example, because movement of
lead 28 has been detected, which may indicate that electrodes 80-83
have moved closer to heart 14.
[0152] In accordance with the description provided in FIG. 4, nerve
capture module 122 may analyze an electrical signal received from
neurostimulation therapy module 106, such as an electrical nerve
signal (e.g., an ENG) or an electrical muscle signal (e.g., EMG),
to detect a physiological response to a stimulation signal
delivered to patient 12 via electrodes 80-83 of lead 28. Cardiac
capture module 124 may analyze a cardiac signal sensed via at least
some of electrodes 80-83 (not shown in FIG. 5) electrically
connected to neurostimulation therapy module 106 to detect a
physiological response to a stimulation signal delivered to patient
12 via electrodes 80-83 of lead 28.
[0153] FIG. 5 shows signal paths for neurostimulation module 104
and cardiac therapy module 106 to transmit a far field cardiac
signal and near field cardiac signal, respectively, to far field
cardiac signal module 126. Far field cardiac signal module 126 may
receive a cardiac signal sensed via sensing module 118 of
neurostimulation therapy module 106, which may be referred to as
the far field cardiac signal because of the relative proximity of
electrodes 80-83 with which sensing module 118 may sense the
cardiac signal to heart 14 (e.g., compared to electrodes 50, 52,
54, 56, 58, 60, 72, 74, and 76 electrically connected to cardiac
therapy module 104). Far field cardiac signal module 126 may
analyze the far field cardiac signal using the techniques described
above to determine the position of lead 28 relative to heart 14.
For example, far field cardiac signal module 126 may determine an
amplitude of the far field cardiac signal and compare it to a
stored threshold amplitude value, or compare or correlate the far
field cardiac signal with a near field cardiac signal. The near
field cardiac signal may be a cardiac signal sensed by sensing
module 114 (FIG. 4) of cardiac therapy module 104, which may be
referred to as "near field" signal because of the relative
proximity of electrodes 50, 52, 54, 56, 58, 60, 72, 74, and 76 with
which sensing module 114 may sense to the cardiac signal to heart
14.
[0154] Impedance module 128 may monitor an impedance between
electrodes of one or more of leads 18, 20, and 22 connected to
cardiac therapy module 104 and electrodes of lead 28 connected to
neurostimulation module 106. In particular, impedance module 128
may communicate with neurostimulation therapy module 106 to
transmit an electrical signal and communicate with cardiac therapy
module 104 receive the sensed signal. Alternatively, impedance
module 128 may communicate with cardiac therapy module 104 to
transmit an electrical signal and communicate with neurostimulation
therapy module 106 to receive the sensed signal. As previously
described, impedance module 128 may determine an electrical
parameter value indicative of an impedance of an electrical path
between electrodes of one or more of leads 18, 20, and 22 and
electrodes of lead 28. The electrical parameter may be, for
example, a current or voltage amplitude of the sensed signal. Based
on the electrical parameter, impedance module 128 may send a
control signal to neurostimulation therapy module 106 via signal
path 121 to selectively withhold delivery of neurostimulation to
patient 12.
[0155] FIG. 6 is block diagram of an example programmer 24. As
shown in FIG. 6, programmer 24 includes processor 130, memory 132,
user interface 134, telemetry module 136, and power source 138.
Programmer 24 may be a dedicated hardware device with dedicated
software for programming of IMD 16. Alternatively, programmer 24
may be an off-the-shelf computing device running an application
that enables programmer 24 to program IMD 16.
[0156] A user may use programmer 24 to select therapy programs
(e.g., sets of stimulation parameters), generate new therapy
programs, modify therapy programs through individual or global
adjustments or transmit the new programs to IMD 16 (FIG. 1). The
therapy programs may be for either or both cardiac therapy module
104 and neurostimulation module 106 (FIG. 4). The clinician may
interact with programmer 24 via user interface 134, which may
include display to present graphical user interface to a user, and
a keypad or another mechanism for receiving input from a user.
[0157] Processor 130 can take the form one or more microprocessors,
DSPs, ASICs, FPGAs, programmable logic circuitry, or the like, and
the functions attributed to processor 130 herein may be embodied as
hardware, firmware, software or any combination thereof. Memory 312
may store instructions that cause processor 130 to provide the
functionality ascribed to programmer 24 herein, and information
used by processor 130 to provide the functionality ascribed to
programmer 24 herein. Memory 132 may include any fixed or removable
magnetic, optical, or electrical media, such as RAM, ROM, CD-ROM,
hard or floppy magnetic disks, EEPROM, or the like. Memory 132 may
also include a removable memory portion that may be used to provide
memory updates or increases in memory capacities. A removable
memory may also allow patient data to be easily transferred to
another computing device, or to be removed before programmer 24 is
used to program therapy for another patient. Memory 132 may also
store information that controls therapy delivery by IMD 16, such as
stimulation parameter values.
[0158] Programmer 24 may communicate wirelessly with IMD 16, such
as using RF communication or proximal inductive interaction. This
wireless communication is possible through the use of telemetry
module 136, which may be coupled to an internal antenna or an
external antenna. An external antenna that is coupled to programmer
24 may correspond to the programming head that may be placed
proximate to the patient's body near the IMD 16 implant site, as
described above with reference to FIG. 1. Telemetry module 136 may
be similar to telemetry module 108 of IMD 16 (FIG. 4).
[0159] Telemetry module 136 may also be configured to communicate
with another computing device via wireless communication
techniques, or direct communication through a wired connection.
Examples of local wireless communication techniques that may be
employed to facilitate communication between programmer 24 and
another computing device include RF communication according to the
802.11 or Bluetooth specification sets, infrared communication,
e.g., according to the IrDA standard, or other standard or
proprietary telemetry protocols. In this manner, other external
devices may be capable of communicating with programmer 24 without
needing to establish a secure wireless connection.
[0160] Power source 138 delivers operating power to the components
of programmer 24. Power source 138 may include a battery and a
power generation circuit to produce the operating power. In some
examples, the battery may be rechargeable to allow extended
operation. Recharging may be accomplished by electrically coupling
power source 138 to a cradle or plug that is connected to an
alternating current (AC) outlet. In addition or alternatively,
recharging may be accomplished through proximal inductive
interaction between an external charger and an inductive charging
coil within programmer 24. In other examples, traditional batteries
(e.g., nickel cadmium or lithium ion batteries) may be used. In
addition, programmer 24 may be directly coupled to an alternating
current outlet to power programmer 24. Power source 138 may include
circuitry to monitor power remaining within a battery. In this
manner, user interface 134 may provide a current battery level
indicator or low battery level indicator when the battery needs to
be replaced or recharged. In some cases, power source 138 may be
capable of estimating the remaining time of operation using the
current battery.
[0161] FIG. 7 illustrates a conceptual illustration of electrical
nerve signal 140 that may be generated by a target nerve in
response to the delivery of neurostimulation therapy by
neurostimulation therapy module 106 (FIG. 4) of IMD 16. Sensing
module 118 (FIG. 4) of neurostimulation therapy module 106 may
generate electrical nerve signal 140 in response to sensed nerve
activity. In the example shown in FIG. 7, the target nerve may be a
vagus nerve of patient 12. Electrical nerve signal 140 includes a
baseline component 142 and a response component 144. Baseline
component 142 represents normal activity of the vagus nerve, e.g.,
activity without the delivery of neurostimulation by
neurostimulation therapy module 106. The vagus nerve generates a
response, as indicated by response component 144, in response to
the delivery of a stimulation signal to target tissue site 40 by
signal generator 116 (FIG. 4) of neurostimulation module 106.
[0162] In the example shown in FIG. 7, response component 144
comprises an amplitude that is greater than or equal to a threshold
amplitude value (as indicated by THRESHOLD in FIG. 7), which
indicates that there is no loss of nerve capture. In other words,
stimulation delivered by neurostimulation module 106 captures the
vagus nerve, as indicated by the amplitude of response component
144 of electrical nerve signal 140. The presence of nerve capture
may indicate that electrodes 80-83 of lead 28 (FIG. 2) are
positioned to deliver stimulation to target tissue site 40 (FIG. 1)
and have not migrated away from target tissue site 40 and, for
example, towards heart 14. As previously described, IMD 16 may
continue to deliver neurostimulation to patient 12 when electrical
signal 144 exhibits response component 144 of a sufficient
amplitude in response to the delivery of neurostimulation by
neurostimulation therapy module 106 because response component 144
indicates that lead 28 is positioned close enough to original
implant site. This may indicate that the delivery of
neurostimulation is not likely to capture heart 14.
[0163] FIG. 8 illustrates an example cardiac signal 150 that may be
generated by sensing module 114 (FIG. 4) of cardiac therapy module
106 of IMD 16 via electrically activity sensed by any combination
of electrodes 50, 52, 54, 56, 58, 60, 68, 72, 74, and 76
electrically connected to cardiac therapy module 104 or via
electrical activity sensed via electrodes 68, 80-83 electrically
connected to neurostimulation therapy module 106. In FIG. 8,
cardiac signal 150 may comprise an ECG or EGM signal. In FIG. 8,
signal 150 includes a baseline cardiac rhythm that includes
baseline cardiac waveforms 152A-152C (hereinafter referred to as
"baseline cardiac waveforms 152") that indicate a normal sinus
rhythm of heart 14, and an evoked response 154.
[0164] Cardiac signal 150 is sensed over a period of time that
includes the time in which stimulation module 116 (FIG. 4) of
neurostimulation module 106 generates and delivers an electrical
stimulation signal, e.g., a test stimulation signal, to target
tissue site 40 via a selected combination of electrodes 80-83 of
neurostimulation lead 28 (FIG. 4). IMD 16 delivers the test
stimulation signal to target tissue site 40 at time T.sub.STIM. As
shown in FIG. 8, cardiac signal 150 exhibits evoked response 154
shortly after neurostimulation therapy module 106 delivers the test
stimulation signal via two or more electrodes 80-83 of lead 28 at
time T.sub.STIM. For example, if the test stimulation signal
captures right atrium 30, the evoked response may be a P-wave
within approximately 40 milliseconds (ms) of delivering of the test
signal, although other time ranges are contemplated. In this
example, an R-wave may follow the P-wave within approximately 250
ms, although other time ranges are contemplated. In these examples,
IMD 16 may deliver the test signal when the AV node is not in
refractory. If, however, IMD 16 delivers the test signal when the
AV node is in refractory the evoked response may be only a P-wave
located within approximately 40 ms of delivery of the test signal.
In this case, an R-wave may not follow the P-wave since the AV node
is in refractory. In an example in which the test signal captures
right ventricle 32, the evoked response may be an R-wave within
approximately 40 ms of delivery of the test signal with no
subsequent P-wave.
[0165] Cardiac capture module 124 (FIG. 5) of lead migration
detection module 120 (FIG. 4) of IMD 16 may analyze electrical
cardiac signal 150 over a window of time following time T.sub.STIM.
In some examples, neurostimulation therapy module 106 delivers the
electrical stimulation signal at a time between normal baseline
cardiac waveforms, and cardiac capture module 124 analyzes the
cardiac signal 150 over a window of time following delivery of the
electrical stimulation signal for an evoked response by heart
14.
[0166] As FIG. 8 illustrates, prior to the delivery of the
neurostimulation signal, the R-waves of each of the baseline
cardiac waveforms 152 are substantially evenly spaced by R--R
interval 156. Because evoked response 154 occurs after baseline
cardiac rhythm 152B, but within a shorter amount of time following
an immediately preceding R-wave than R--R interval 156, cardiac
capture module 124 may determine that evoked response 154 was in
fact a response to the delivery of the neurostimulation signal,
rather than a normal cardiac rhythm of patient 12. Cardiac capture
module 124 may determine that because evoked response 154 was
detected following time T.sub.STIM, the neurostimulation signal
captured heart 14, thereby indicating that lead 28 may have
migrated toward heart 14.
[0167] Cardiac capture module 124 may, in one example, compare an
amplitude of cardiac signal 150 after time T.sub.STIM to a
threshold value, and detect evoked response 154 when the amplitude
of cardiac signal 150 is greater than the threshold value. The
threshold value may be an amplitude value of a typical R-wave for
P-wave for the patient's cardiac rhythm. Other techniques for
detecting an evoked response are contemplated. It is recognized
that the detection method may vary based on the type of evoked
response that can be expected as a result of a neurostimulation
pulse.
[0168] In the example shown in FIG. 8, evoked response 154 is a
cardiac waveform similar to baseline cardiac waveforms 152, but may
take other forms. Other examples of an evoked response include a
distorted variation of a normal sinus rhythm such as a P-wave, an
R-wave, or other waveform of a sinus rhythm that is not
synchronized with the normal sinus rhythm of patient 12.
[0169] FIGS. 9-12 are flow diagrams of example techniques for
selectively controlling neurostimulation therapy to patient 12 upon
determining that neurostimulation lead 28 may have moved such that
electrodes 80-83 of lead 28 have migrated towards heart 14.
[0170] FIG. 9 is a flow diagram of an example technique for
selectively withholding delivery of neurostimulation therapy to
patient 12 based on detecting a loss of nerve capture with
electrodes of neurostimulation lead 28 (FIG. 4). IMD 16 may deliver
an electrical stimulation signal to patient 12 (200). As previously
described, signal generator 116 of neurostimulation module 106 may
generate a test stimulation signal and deliver the test stimulation
signal to target tissue site 40 (FIG. 1) via one or more of
electrodes 80-83 of lead 28. The stimulation signal may comprise,
for example, a pulse waveform having a frequency of about 1 Hz and
an amplitude of about 8 V. In some examples, the stimulation signal
is not configured to provide neurostimulation therapy, e.g.,
therapeutic benefits to patient 12. Rather, the stimulation signal
may be configured to trigger a physiological response from the
target nerve or tissue proximate to the vagus nerve, such as
laryngeal muscle tissue or other muscle tissue. However, in some
examples, the test stimulation signal may be configured to provide
neurostimulation therapy to patient 12.
[0171] After the test stimulation signal is delivered to patient 12
via neurostimulation lead 28 (200), sensing module 118 (FIG. 4) of
neurostimulation therapy module 106 may sense an electrical nerve
signal, e.g., via a subset of electrodes 80-83 of lead 28. Nerve
capture module 122 (FIG. 4) of lead migration detection module 120
(FIG. 4) of IMD 16 may analyze the electrical nerve signal (202) to
determine whether the delivery of the test stimulation signal
resulted in a physiological response (204). That is, nerve capture
module 122 may analyze the electrical nerve signal to determine if
the stimulation signal captured the target nerve (e.g., the vagus
nerve). An example electrical nerve signal is shown in FIG. 7.
[0172] In other examples, nerve capture module 122 also analyzes an
electrical signal that is indicative of other physiological
responses, such as muscle movement, to the delivery of the test
stimulation signal, as previously described. Nerve capture module
122 may analyze the electrical nerve signal to determine whether
the nerve was captured by, for example, comparing an amplitude of
the electrical nerve signal to a predetermined threshold amplitude
value stored in memory 102 (FIG. 4) of IMD 16. In particular, nerve
capture module 122 may analyze a portion of the electrical nerve
signal that corresponds to a time interval following delivery of
the test stimulation signal by neurostimulation therapy module
106.
[0173] If nerve capture module 122 detects a response to the
stimulation signal, processor 100 may determine that electrodes
80-83 of lead 28 have not migrated away from target tissue site 40.
Thus, if nerve capture module 122 detects a response to the
stimulation signal, i.e., nerve capture, IMD 16 may continue to
periodically perform technique shown in FIG. 9. For example, IMD 16
may repeat the steps of FIG. 9 on a weekly basis, a daily basis, an
hourly basis, or several times per day.
[0174] If, however, nerve capture module 122 does not detect a
response to the stimulation signal, processor 100 may determine
lead 28 has moved such that there is a loss of nerve capture by the
neurostimulation. Processor 100 may control neurostimulation
therapy module 106 to withhold the delivery of neurostimulation to
patient 12 (206). Loss of nerve capture may indicate that lead 28
has migrated from the target tissue site 40. Because there is a
possibility that lead 28 may have migrated to a position where
neurostimulation therapy may be coupled to heart 14, IMD 16 may
withhold delivery of neurostimulation therapy.
[0175] As previously described, IMD 16 may take further action
after detecting a loss of nerve capture. For example, IMD 16 may
communicate with programmer 24 to provide an alert to patient 12
(or patient caretaker) or a clinician that there is a loss of nerve
capture. Additionally or alternatively, IMD 16 may generate an
alert, such as a beeping sound or a vibrational pattern, to
indicate the loss of nerve capture. A clinician may then use
imaging procedures to determine the position of lead 28 and take
action based on the position of lead 28.
[0176] FIG. 10 is a flow diagram of an example technique for
selectively withholding delivery of neurostimulation therapy to
patient 12 based on the detection of cardiac capture by stimulation
delivered via a neurostimulation signal. Signal generator 116 of
neurostimulation therapy module 106 (FIG. 4) may deliver a test
stimulation signal to patient 12 (200). Either sensing module 114
of cardiac therapy module 104 (FIG. 4) or sensing module 118 of
neurostimulation therapy module 106 (FIG. 4) may sense a cardiac
signal (e.g., an EGM or ECG signal) following the delivery of the
test stimulation signal. Cardiac capture module 124 (FIG. 5) of
lead migration detection module 120 (FIG. 4) of IMD 16 may analyze
the sensed cardiac signal (212) to detect a response to the test
stimulation (214). In particular, cardiac capture module 124 may
analyze the sensed cardiac signal to determine if the stimulation
resulted in cardiac capture, e.g., whether the test stimulation
evoked a response by heart 14. Cardiac capture may result from the
delivery of the test stimulation via electrodes of neurostimulation
lead 28 if electrodes 80-83 of neurostimulation lead 28 have
migrated within a particular distance range of heart 14.
[0177] In some examples, cardiac capture module 124 may determine
whether the test stimulation signal captured heart 14, e.g.,
whether electrodes 80-83 of neurostimulation lead 28 have migrated
within the particular range of heart 14, by comparing an amplitude
of the sensed cardiac signal to a predetermined threshold amplitude
value stored in memory 102 (FIG. 4) of IMD 16. In particular,
cardiac capture module 124 may analyze a portion of the electrical
cardiac signal that corresponds to a time interval following
delivery of the stimulation signal. An example cardiac signal is
shown in FIG. 8.
[0178] If cardiac capture module 124 does not detect a
physiological response to the stimulation signal, IMD 16 may
continue to periodically repeat technique shown in FIG. 10. For
example, IMD 16 may repeat the steps of FIG. 10 on a weekly basis,
a daily basis, an hourly basis, or several times per day. If,
however, cardiac capture module 124 detects an evoked cardiac
response to the test stimulation signal, processor 100 may
determine the test stimulation signal captured heart 14. Processor
100 may then control neurostimulation therapy module 106 to
withhold the delivery of neurostimulation to patient 12 (206).
Cardiac capture may indicate that lead 28 has migrated from target
tissue site 40. Consequently, IMD 16 may suspend the delivery of
neurostimulation therapy.
[0179] As previously described with respect to the example method
shown in FIG. 9, IMD 16 may take further action after detecting a
loss of nerve capture. For example, IMD 16 may generate an alert to
warn patient 12 or a clinician that neurostimulation therapy has
been suspended, e.g., by communicating with programmer 24 or by
emitting an audible alert or vibrations.
[0180] FIG. 11 is a flow diagram of an example technique for
selectively withholding delivery of neurostimulation therapy to
patient 12 based on a far field cardiac signal, which may be, for
example, an EGM or an ECG sensed via two or more electrodes 80-83
(FIG. 4) electrically connected to neurostimulation therapy module
106. The far field cardiac signal may indicate the position of lead
28 relative to heart 14, which may be used to control the delivery
of neurostimulation therapy to patient 12.
[0181] In accordance with the technique shown in FIG. 11, IMD 16
may sense electrical cardiac signals via one or more of electrodes
80-83 of neurostimulation lead 28 (220). In particular, sensing
module 118 (FIG. 4) of neurostimulation module 106 may sense the
cardiac signals and generate the far field cardiac signal. Far
field cardiac signal module 126 (FIG. 5) of lead migration
detection module 120 (FIG. 4) may analyze the far field ECG or EGM
signal (222) to determine the position of electrodes 80-83 of
neurostimulation lead 28 relative to heart 14. As one example, far
field cardiac signal module 126 (FIG. 5) may compare an amplitude,
or other signal characteristic, such as a polarity, morphology, or
frequency content, of the far field cardiac signal to a
predetermined threshold value.
[0182] In another example, far field cardiac signal module 126 may
also analyze the far field ECG or EGM signal to determine a ratio
of the size of a P-wave and an R-wave. As another example, far
field cardiac signal module 126 may analyze the far field ECG or
EGM signal by comparing the far field signal to a corresponding
near field signal. In any case, far field cardiac signal module 126
determines the position of lead 28 relative to heart 14 based on
the comparison (224). With respect to the example in which far
field cardiac signal module 126 analyzes the amplitude of the far
field signal, the amplitude of the far field cardiac signal may be
a mean or median amplitude over a predetermined period of time or a
change in amplitude of the cardiac signal over time (e.g., a
slope). If the amplitude of the far field cardiac signal sensed via
the neurostimulation electrodes 80-83 is not greater than a stored
threshold value, far field cardiac signal module 126 may determine
that neurostimulation electrodes 80-83 have not moved within a
threshold distance away from target tissue site 40 and toward heart
14 (224) and IMD 16 may continue to deliver neurostimulation to
patient 12. The threshold distance can be, for example, a distance
away from target tissue site 40 that indicates electrodes 80-83
have migrated a sufficient distance toward heart 14 such that
stimulation delivered via electrodes 80-83 may capture heart
14.
[0183] As discussed above, an overall amplitude of the far field
cardiac signal may increase as the neurostimulation electrodes
80-83 move closer to heart 14. Accordingly, if the amplitude of the
far field cardiac signal sensed via the neurostimulation electrodes
80-83 is greater or equal to a stored threshold value, far field
cardiac signal module 126 may determine that neurostimulation
electrodes 80-83 have migrated towards heart 14. Accordingly, far
field cardiac signal module may control neurostimulation therapy
module 106 to withhold the delivery of neurostimulation to patient
12 (206). Far field cardiac signal module 126 may also generate an
interference indication that is transmitted to programmer 24 and/or
generate an alert to notify patient 12 that neurostimulation
therapy has been suspended.
[0184] FIG. 12 is a flow diagram illustrating an example technique
for selectively withholding neurostimulation therapy to patient 12
based on an impedance of an electrical path between electrodes 50,
52, 54, 56, 58, 60, 68, 72, 74, and 76 electrically connected to
cardiac therapy module 104 (FIG. 4) and electrodes 68, 80, 81, 82
and/or 83 electrically connected to neurostimulation therapy module
106 (FIG. 4). IMD 16 may generate and deliver an electrical signal
from electrodes of a first lead (230) and sense the electrical
signal with electrodes of a second lead (232). In one example, the
first lead may be a neurostimulation lead, e.g., lead 28, and the
second lead may be a cardiac lead, such as one of leads 18, 20, and
22. In such an example, signal generator 116 (FIG. 4) of
neurostimulation module 106 may generate the electrical signal and
sensing module 114 (FIG. 4) of cardiac therapy module 104 may sense
the electrical signal. In another example, the first lead may be a
cardiac lead, such as one of leads 18, 20, and 22, and the second
lead may be a neurostimulation lead, e.g., lead 28. In such an
example, signal generator 112 (FIG. 4) of cardiac therapy module
104 may generate the electrical signal and sensing module 118 (FIG.
4) of neurostimulation module 106 may sense the electrical signal.
The electrical signal used to determine impedance may not be
configured to provide therapeutic benefits to patient 12. That is,
the electrical signal may be configured such that it does not
activate tissue, e.g., a nerve or muscle, and thus, does not
provide a therapeutic benefit to patient 12. However, in some
examples, the electrical signal delivered to determine the
impedance of the electrical path may provide therapeutic benefits
to patient 12.
[0185] Based on the sensed electrical signal and the known
characteristics of the delivered electrical signal, impedance
module 128 (FIG. 5) of lead migration detection module 120 (FIG. 4)
of IMD 16 may determine an electrical parameter value indicative of
an impedance of the electrical path between the electrodes of the
first lead and the electrodes of the second lead (234). For
example, impedance module 128 may determine a current amplitude of
the sensed electrical signal, which may be indicative of the
impedance of the electrical path if the voltage amplitude of the
electrical signal delivered via the first lead is known. As another
example, impedance module 128 may determine a voltage amplitude of
the sensed electrical signal, which may be indicative of the
impedance of the electrical path if the current amplitude of the
electrical signal delivered via the first lead is known.
[0186] Impedance module 128 may compare the electrical parameter
value indicative of impedance to a predetermined threshold value
(236). Changes in an impedance of the electrical path between the
electrodes of the first and second leads may indicate that one of
the leads has moved. As previously described, movement of lead 28
towards leads 18, 20, 22 may be undesirable because movement of
lead 28 toward leads 18, 20, 22 may indicate electrodes 80-83 of
lead 28 have moved toward heart 14. Movement of electrodes 80-83
proximate to heart 14 may be undesirable because of the possibility
that the neurostimulation signals generated by signal generator 116
of neurostimulation therapy module 106 may inadvertently capture
heart 14. Movement of lead 28 toward heart 14 may also decrease the
efficacy of the neurostimulation therapy because of the movement
away from the target nerve.
[0187] If the electrical parameter value indicative of impedance of
the electrical path between electrodes of lead 28 and electrodes of
one or more of leads 18, 20, 22 has not abruptly changed, impedance
module 128 may determine that the position of lead 28 relative to
heart 14 is acceptable and indicates lead 28 has not migrated from
target tissue site 40. IMD 16 may continue to periodically
implement technique shown in FIG. 12. For example, IMD 16 may
repeat the steps of FIG. 12 on a weekly basis, a daily basis, an
hourly basis, or several times per day. If, however, the electrical
parameter value indicative of impedance of the electrical path
between electrodes of lead 28 and electrodes of one or more of
leads 18, 20, 22 is less than the stored threshold value, processor
100 of IMD 16 may control neurostimulation therapy module 106 to
withhold the delivery of neurostimulation to patient 12 (206).
Processor 100 may also generate an interference indication that is
transmitted to programmer 24 and/or generate an alert to notify
patient 12 that neurostimulation therapy has been suspended.
[0188] The techniques described in this disclosure, including those
attributed to IMD 16, programmer 24, or various constituent
components, may be implemented, at least in part, in hardware,
software, firmware or any combination thereof. For example, various
aspects of the techniques may be implemented within one or more
processors, including one or more microprocessors, DSPs, ASICs,
FPGAs, or any other equivalent integrated or discrete logic
circuitry, as well as any combinations of such components, embodied
in programmers, such as physician or patient programmers,
stimulators, image processing devices or other devices. The term
"processor" or "processing circuitry" may generally refer to any of
the foregoing logic circuitry, alone or in combination with other
logic circuitry, or any other equivalent circuitry.
[0189] Such hardware, software, firmware may be implemented within
the same device or within separate devices to support the various
operations and functions described in this disclosure. While the
techniques described herein are primarily described as being
performed by processor 100 of IMD 16 and/or processor 130 of
programmer 24, any one or more parts of the techniques described
herein may be implemented by a processor of IMD 16, programmer 24
or another computing device, alone or in combination with IMD 16 or
programmer 24.
[0190] In addition, any of the described units, modules or
components may be implemented together or separately as discrete
but interoperable logic devices. Depiction of different features as
modules or units is intended to highlight different functional
aspects and does not necessarily imply that such modules or units
must be realized by separate hardware or software components.
Rather, functionality associated with one or more modules or units
may be performed by separate hardware or software components, or
integrated within common or separate hardware or software
components.
[0191] When implemented in software, the functionality ascribed to
the systems, devices and techniques described in this disclosure
may be embodied as instructions on a computer-readable medium such
as RAM, ROM, NVRAM, EEPROM, FLASH memory, magnetic data storage
media, optical data storage media, or the like. The instructions
may be executed to support one or more aspects of the functionality
described in this disclosure.
[0192] Various examples have been described. These and other
examples are within the scope of the following example
statements.
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